Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema (IVT)

• ClinicalTrials.gov Identifier: NCT00367133
• Recruitment Status: Completed
• First Posted: August 22, 2006
• Results First Posted: July 9, 2010
• Last Update Posted: August 26, 2016
• Sponsor: Jaeb Center for Health Research
• Collaborators: National Eye Institute (NEI); Allergan
• Information provided by (Responsible Party): Jaeb Center for Health Research

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Diabetic Macular Edema
• Interventions: Procedure: Standard of Care Group; Drug: 1mg triamcinolone acetonide; Drug: 4mg triamcinolone acetonide
• Enrollment: 840

Participant Flow

Recruitment Details	Eighty-eight academic and community based sites across the United States recruited 693 subjects from May 2004 to July 2006.
Pre-assignment Details

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Period Title: 2 Years
Started	330 [1]	256 [1]	254 [1]
Completed	272	220	205
Not Completed	58	36	49
Reason Not Completed
Death	20	12	12
Dropped	34	19	33
Missed visit	4	5	4
[1] Number of Eyes
Period Title: 3 Years
Started	143 [1]	116 [1]	116 [1]
Completed	115	93	98
Not Completed	28	23	18
[1] Since trial ended early, includes only those with potential for 3 year follow-up -excludes deaths

Baseline Characteristics

Arm/Group Title		Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone	Total
Arm/Group Description		Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide	Total of all reporting groups
Overall Number of Baseline Participants		330	256	254	840
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Median (Inter-Quartile Range); Unit of measure: Years
	Number Analyzed	330 participants	256 participants	254 participants	840 participants
		63; (57 to 69)	63; (58 to 70)	63; (57 to 69)	63; (57 to 70)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	330 participants	256 participants	254 participants	840 participants
	Female	166 50.3%	120 46.9%	125 49.2%	411 48.9%
	Male	164 49.7%	136 53.1%	129 50.8%	429 51.1%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	330 participants	256 participants	254 participants	840 participants
White		243	186	183	612
Black		31	22	26	79
Hispanic or Latino		39	34	33	106
Asian		7	8	5	20
American Indian/Alaskan Native		2	2	2	6
Native Hawaiian/other Pacific Islander		1	0	1	2
More than 1 race		1	1	0	2
Unknown/not reported		6	3	4	13
Diabetes Type; Measure Type: Number; Unit of measure: Participants	Number Analyzed	330 participants	256 participants	254 participants	840 participants
Type 1		14	12	12	38
Type 2		316	244	242	802
History of ocular hypertension; Measure Type: Number; Unit of measure: Eyes	Number Analyzed	330 participants	256 participants	254 participants	840 participants
Ocular Hypertension		3	8	4	15
No Ocular Hypertension		327	248	250	825
Lens status phakic (clinical examination); Measure Type: Number; Unit of measure: Eyes	Number Analyzed	330 participants	256 participants	254 participants	840 participants
Phakic		262	203	197	662
Pseudophakic		68	53	57	178
OCT cystoid abnormality (questionable or definite); Measure Type: Number; Unit of measure: Eyes	Number Analyzed	330 participants	256 participants	254 participants	840 participants
OCT cystoid abnormality (questionable or definite)		315	243	246	804
No Evidence		12	9	6	27
Missing/can not grade		3	4	2	9
OCT subretinal fluid present (questionable or definite; Measure Type: Number; Unit of measure: Eyes	Number Analyzed	330 participants	256 participants	254 participants	840 participants
OCT subretinal fluid present		94	64	61	219
Missing (or ungradeable)		1	4	1	6
No OCT subretinal fluid present		235	188	192	615
Prior Panretinal scatter photocoagulation; Measure Type: Number; Unit of measure: Eyes	Number Analyzed	330 participants	256 participants	254 participants	840 participants
Prior Panretinal scatter photocoagulation		53	40	42	135
No Prior Panretinal scatter photocoagulation		277	216	212	705
Prior photocoagulation for diabetic macular edema; Measure Type: Number; Unit of measure: Eyes	Number Analyzed	330 participants	256 participants	254 participants	840 participants
Prior photocoagulation for DME		198	154	158	510
No Prior photocoagulation for DME		132	102	96	330
Retinopathy severity (ETDRS severity scale) [1]; Measure Type: Number; Unit of measure: Eyes	Number Analyzed	330 participants	256 participants	254 participants	840 participants
Microaneurysms only		1	1	0	2
Mild-moderately severe nonproliferative		186	156	151	493
Severe nonproliferative		43	27	25	95
Mild to moderate proliferative		79	56	62	197
High-risk proliferative		9	8	6	23
Missing (ungradeable)		12	8	10	30
		[1] Measure Description: Early Treatment Diabetic Retinopathy Study (ETDRS) scale. Retinopathy severity data missing for: 12, 8, 10 eyes in the Laser, 1mg and 4mg treatment groups, respectively.
Visual Acuity Categorized by Randomization Strata [1]; Measure Type: Number; Unit of measure: Eyes	Number Analyzed	330 participants	256 participants	254 participants	840 participants
73-60 (20/32-2-20/62)		189	149	149	487
59-36 (<20/631-20/200)		129	94	92	315
35-24 (20/200-20/320)		12	13	13	38
		[1] Measure Description: Letter score and approximate Snellen equivalent. Best score is 97, worst is 0.
Central subfield thickness on OCT [1]; Median (Inter-Quartile Range); Unit of measure: Microns
	Number Analyzed	330 participants	256 participants	254 participants	840 participants
		398; (329 to 505)	405; (327 to 514)	396; (323 to 484)	400; (323 to 514)
		[1] Measure Description: Mean of two baseline scans. Mean CST <250 microns based on RC grading in 15, 7, and 5 eyes for laser, 1 mg, and 4 mg groups, respectively. Missing/ungradable optical coherence tomography or fundus photo data for 1, 2, and 1 eyes for laser, 1 mg, and 4 mg groups, respectively.
Duration of Diabetes; Median (Inter-Quartile Range); Unit of measure: Years
	Number Analyzed	330 participants	256 participants	254 participants	840 participants
		15; (9 to 21)	15; (9 to 21)	16; (10 to 22)	15; (9 to 22)
HbA1c [1]; Median (Inter-Quartile Range); Unit of measure: Percentage
	Number Analyzed	330 participants	256 participants	254 participants	840 participants
		7.5; (6.6 to 8.5)	7.5; (6.8 to 8.4)	7.6; (6.8 to 8.8)	7.5; (6.6 to 8.8)
		[1] Measure Description: Missing HbA1c data in 64, 46, and 50 in the laser, 1 mg, and 4 mg groups respectively
Intraocular pressure; Median (Inter-Quartile Range); Unit of measure: Microns
	Number Analyzed	330 participants	256 participants	254 participants	840 participants
		16; (13 to 18)	16; (13 to 18)	16; (14 to 18)	16; (13 to 18)
Retinal volume on OCT [1]; Median (Inter-Quartile Range); Unit of measure: Cubic millimetre
	Number Analyzed	330 participants	256 participants	254 participants	840 participants
		9.2; (7.9 to 10.6)	8.9; (7.8 to 10.5)	8.9; (7.9 to 10.0)	9.0; (7.8 to 10.6)
		[1] Measure Description: Missing/ungradeable optical coherence tomography and fundus photo data for the laser, 1mg, and 4 mg groups respectively: 37, 36, 48.
e-ETDRS visual acuity [1]; Median (Inter-Quartile Range); Unit of measure: Letter Score
	Number Analyzed	330 participants	256 participants	254 participants	840 participants
		62; (53 to 67)	62; (54 to 67)	62; (52 to 67)	62; (52 to 67)
		[1] Measure Description: Best corrected visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. Best value on the scale 97, worst 0.

Outcome Measures

1. Primary Outcome

Title	Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.
Description	Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Time Frame	Baseline to 2 Years

Outcome Measure Data

Analysis Population Description

The primary analysis included all randomized eyes and followed the intent-to-treat principle.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	330	256	254
Mean (Standard Deviation); Unit of Measure: Letter score
	1 (17)	-2 (18)	-3 (22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Focal/Grid Laser Photocoagulation, 1mg Intravitreal Triamcinolone
	Comments	P values for two group comparisons for difference in mean change.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.02
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Focal/Grid Laser Photocoagulation, 4 mg Intravitreal Triamcinolone
	Comments	P Values for 2 group comparisons of difference in mean change
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	1mg Intravitreal Triamcinolone, 4 mg Intravitreal Triamcinolone
	Comments	P Values for 2 group comparisons of difference in mean change
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.49
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes

2. Primary Outcome

Title	Median Change in Visual Acuity Baseline to 2 Years
Description	Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.
Time Frame	Baseline to 2 Years

Outcome Measure Data

Analysis Population Description

The primary analysis included all randomized eyes and followed the intent-to-treat principle.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	330	256	254
Median (Inter-Quartile Range); Unit of Measure: Letter score
	4; (-6 to 11)	1; (-11 to 9)	2; (-11 to 11)

3. Primary Outcome

Title	Distribution of Change in Visual Acuity Baseline to 2 Years
Description	Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
Time Frame	baseline to 2 years

Outcome Measure Data

Analysis Population Description

The primary analysis included all randomized eyes and followed the intent-to-treat principle

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	330	256	254
Measure Type: Number; Unit of Measure: Percentage of Eyes
>= 15 letter improvement	18	14	17
14 to 10 letter improvement	13	11	11
9 to 5 letter improvement	16	14	15
same +- 4 letters	24	27	23
5-9 letters worse	10	9	6
10-14 letters worse	5	6	8
>=15 letters worse	14	20	20

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Focal/Grid Laser Photocoagulation, 1mg Intravitreal Triamcinolone
	Comments	Proportion with 15-letter or more worsening
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.03
	Comments	[Not Specified]
	Method	GEE Repeated Measures
	Comments	Hochberg procedure used to determine statistical significance.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Focal/Grid Laser Photocoagulation, 4 mg Intravitreal Triamcinolone
	Comments	Proportion with 15-letter or more worsening
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	GEE Repeated Measures
	Comments	Hochberg procedure used to determine statistical significance.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	1mg Intravitreal Triamcinolone, 4 mg Intravitreal Triamcinolone
	Comments	Proportion with 15-letter or more worsening
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.82
	Comments	[Not Specified]
	Method	GEE Repeated Measures
	Comments	Hochberg procedure used to determine statistical significance.

4. Secondary Outcome

Title	Central Subfield Thickness at 2 Years
Description	Median central subfield thickness at two-years. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

Only subjects with an available Optical coherence tomography (OCT) at baseline and 2 years are included in the OCT analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	261	207	193
Median (Inter-Quartile Range); Unit of Measure: Microns
	243; (197 to 326)	305; (231 to 406)	279; (228 to 430)

5. Secondary Outcome

Title	Mean Change in Central Subfield Thickness Baseline to 2 Years
Description	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes and improvement.
Time Frame	Baseline to 2 years

Outcome Measure Data

Analysis Population Description

Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	261	207	193
Mean (Standard Deviation); Unit of Measure: Microns
	-139 (148)	-86 (167)	-77 (160)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Focal/Grid Laser Photocoagulation, 1mg Intravitreal Triamcinolone
	Comments	P value not adjusted for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Focal/Grid Laser Photocoagulation, 4 mg Intravitreal Triamcinolone
	Comments	P Value not adjusted for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	1mg Intravitreal Triamcinolone, 4 mg Intravitreal Triamcinolone
	Comments	P Values not adjusted for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.91
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.

6. Secondary Outcome

Title	Median Change in Central Subfield Thickness Baseline to 2 Years
Description	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Time Frame	Baseline to 2 Years

Outcome Measure Data

Analysis Population Description

Only subjects with an available OCT's at baseline and 2 years are included in the OCT analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	261	207	193
Median (Inter-Quartile Range); Unit of Measure: Microns
	-131; (-217 to -49)	-74; (-168 to -3)	-76; (-175 to 11)

7. Secondary Outcome

Title	Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years
Description	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Time Frame	Baseline to 2 Years

Outcome Measure Data

Analysis Population Description

Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	261	207	193
Measure Type: Number; Unit of Measure: Percentage of Eyes
	67	46	48

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Focal/Grid Laser Photocoagulation, 1mg Intravitreal Triamcinolone
	Comments	P Values not adjusted for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	GEE Repeated Measures
	Comments	Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Focal/Grid Laser Photocoagulation, 4 mg Intravitreal Triamcinolone
	Comments	P Values not adjusted for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	GEE Repeated Measures
	Comments	Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	1mg Intravitreal Triamcinolone, 4 mg Intravitreal Triamcinolone
	Comments	P Value not adjusted for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.60
	Comments	[Not Specified]
	Method	GEE Repeated Measures
	Comments	Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.

8. Secondary Outcome

Title	Central Subfield Thickness < 250 Microns at 2 Years
Description	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	261	207	193
Measure Type: Number; Unit of Measure: Percentage of Eyes
	53	34	38

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Focal/Grid Laser Photocoagulation, 1mg Intravitreal Triamcinolone
	Comments	P Values not adjusted for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	GEE Repeated Measures
	Comments	Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Focal/Grid Laser Photocoagulation, 4 mg Intravitreal Triamcinolone
	Comments	P Value not adjusted for statistical analysis
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	GEE Repeated Measures
	Comments	Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	1mg Intravitreal Triamcinolone, 4 mg Intravitreal Triamcinolone
	Comments	P Value not adjusted for statistical analysis
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.55
	Comments	[Not Specified]
	Method	GEE Repeated Measures
	Comments	Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.

9. Secondary Outcome

Title	Change in Visual Acuity From Baseline to 3 Years
Description	Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.
Time Frame	Baseline to 3 year

Outcome Measure Data

Analysis Population Description

The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	115	93	98
Mean (Standard Deviation); Unit of Measure: Letter Score
	5 (17)	0 (16)	0 (21)

10. Secondary Outcome

Title	Change in Visual Acuity From Baseline to 3 Years
Description	Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best Value on the scale=97, Worst Value=0
Time Frame	Baseline to 3 year

Outcome Measure Data

Analysis Population Description

The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	115	93	98
Median (Inter-Quartile Range); Unit of Measure: Letter Score
	8; (-2 to 15)	2; (-11 to 9)	4; (-8 to 14)

11. Secondary Outcome

Title	Distribution of Visual Acuity Change Baseline to 3 Years
Description	Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale=97, worst=0
Time Frame	Baseline to 3 years

Outcome Measure Data

Analysis Population Description

The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	115	93	98
Measure Type: Number; Unit of Measure: Percentage of Eyes
>= 15 letters better	26	20	21
10-14 letters better	18	4	16
5-9 letters better	18	17	9
no change, + - 4 letters	21	23	24
5-9 letters worse	4	10	6
10-14 letters worse	4	9	6
>=15 letters worse	8	17	16

12. Secondary Outcome

Title	Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years
Description	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	111	87	89
Median (Inter-Quartile Range); Unit of Measure: Microns
	211; (175 to 271)	269; (210 to 299)	248; (195 to 342)

13. Secondary Outcome

Title	Change in Central Subfield Thickness on OCT Baseline to 3 Years
Description	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Time Frame	Baseline to 3 years

Outcome Measure Data

Analysis Population Description

The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	111	87	89
Mean (Standard Deviation); Unit of Measure: Microns
	-175 (149)	-124 (184)	-126 (159)

14. Secondary Outcome

Title	Change in Central Subfield Thickness on OCT Baseline to 3 Years
Description	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Time Frame	baseline to 3 years

Outcome Measure Data

Analysis Population Description

The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	111	87	89
Median (Inter-Quartile Range); Unit of Measure: Microns
	-158; (-273 to -75)	-103; (-248 to 4)	-114; (-224 to -50)

15. Secondary Outcome

Title	Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years
Description	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Time Frame	Baseline to 3 years

Outcome Measure Data

Analysis Population Description

The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.

Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description:	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed	111	87	89
Measure Type: Number; Unit of Measure: Percentage of Eyes
	68	43	51

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
Arm/Group Description	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.	Intravitreal injection of 1mg of triamcinolone acetonide	Intravitreal injection of 4mg of triamcinolone acetonide
All-Cause Mortality
	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	135/330 (40.91%)	69/256 (26.95%)	54/254 (21.26%)
Blood and lymphatic system disorders
Anaemia * 1	3/330 (0.91%)	0/256 (0.00%)	2/254 (0.79%)
Blood count abnormal * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Blood electrolytes decreased * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Blood glucose abnormal * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Blood glucose decreased * 1	2/330 (0.61%)	0/256 (0.00%)	1/254 (0.39%)
Blood glucose increased * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Haemolytic anaemia * 1	2/330 (0.61%)	0/256 (0.00%)	1/254 (0.39%)
Normochromic normocytic anaemia * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Cardiac disorders
Acute myocardial infarction * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Angina unstable * 1	2/330 (0.61%)	0/256 (0.00%)	1/254 (0.39%)
Atrial flutter * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Atrioventricular block * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Bradycardia * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Cardiac arrest * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Cardiac failure congestive * 1	18/330 (5.45%)	4/256 (1.56%)	3/254 (1.18%)
Cardio-respiratory arrest * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Cardiomyopathy * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Coronary artery disease * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Heart rate increased * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Heart rate irregular * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Myocardial infarction * 1	16/330 (4.85%)	2/256 (0.78%)	3/254 (1.18%)
Pulse absent * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Transient ischaemic attack * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Endocrine disorders
Diabetes mellitus * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Diabetic coma * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Diabetic complications * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Hyperparathyroidism * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Eye disorders
Blindness * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Cataract * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Diabetic retinopathy * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Visual acuity reduced * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Vitreous floaters * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Gastrointestinal disorders
Crohn's disease * 1	2/330 (0.61%)	0/256 (0.00%)	2/254 (0.79%)
Diarrhoea * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Diverticulitis * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Diverticulum * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Gastric bypass * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Gastroenteritis viral * 1	2/330 (0.61%)	0/256 (0.00%)	2/254 (0.79%)
Gastrointestinal haemorrhage * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Gastrointestinal infection * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Gastrointestinal injury * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Impaired gastric emptying * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Lower gastrointestinal haemorrhage * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
General disorders
Abdominal discomfort * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Abdominal hernia * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Abdominal pain * 1	4/330 (1.21%)	1/256 (0.39%)	2/254 (0.79%)
Chest pain * 1	9/330 (2.73%)	1/256 (0.39%)	3/254 (1.18%)
Colostomy closure * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Convulsion * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Death * 1	9/330 (2.73%)	1/256 (0.39%)	1/254 (0.39%)
Dehydration * 1	2/330 (0.61%)	0/256 (0.00%)	2/254 (0.79%)
Dizziness * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Fall * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Generalised oedema * 1	2/330 (0.61%)	0/256 (0.00%)	1/254 (0.39%)
Head injury * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Headache * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Hernia * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Hyperglycaemia * 1	2/330 (0.61%)	1/256 (0.39%)	0/254 (0.00%)
Hyperkalaemia * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Hypoglycaemia * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Hypoxia * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Intermittent claudication * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Limb injury * 1	2/330 (0.61%)	1/256 (0.39%)	1/254 (0.39%)
oedema * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Oedema peripheral * 1	2/330 (0.61%)	2/256 (0.78%)	0/254 (0.00%)
Pain in extremity * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Shunt malfunction * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Tobacco abuse * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Vertigo * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Hepatobiliary disorders
Cholecystitis * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Cholecystitis acute * 1	2/330 (0.61%)	0/256 (0.00%)	2/254 (0.79%)
Cholelithiasis * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Infections and infestations
Erysipelas * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Localised infection * 1	5/330 (1.52%)	3/256 (1.17%)	1/254 (0.39%)
Post procedural infection * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Pseudomonas infection * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Septic shock * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Skin bacterial infection * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Volvulus * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Wound infection staphylococcal * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Injury, poisoning and procedural complications
Road traffic accident * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Thermal burn * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Musculoskeletal and connective tissue disorders
Arthritis * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Compression fracture * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Femur fracture * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Gout * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Hip fracture * 1	5/330 (1.52%)	0/256 (0.00%)	2/254 (0.79%)
Humerus fracture * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Intervertebral disc protrusion * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Joint swelling * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Knee arthroplasty * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Lumbar spinal stenosis * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Meniscus lesion * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Osteoarthritis * 1	2/330 (0.61%)	2/256 (0.78%)	0/254 (0.00%)
Osteomyelitis * 1	3/330 (0.91%)	1/256 (0.39%)	1/254 (0.39%)
Pelvic fracture * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Rib fracture * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Spinal compression fracture * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Colonoscopy abnormal * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Oesophageal carcinoma * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Prostate cancer * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Nervous system disorders
Hydrocephalus * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Psychiatric disorders
Dementia * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Mental disorder * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Psychotic disorder * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Vascular dementia * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Renal and urinary disorders
Bladder transitional cell carcinoma * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Dialysis * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Kidney infection * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Nephropathy toxic * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Nephrotic syndrome * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Renal disorder * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Renal failure * 1	6/330 (1.82%)	2/256 (0.78%)	0/254 (0.00%)
Renal failure acute * 1	3/330 (0.91%)	1/256 (0.39%)	0/254 (0.00%)
Renal failure chronic * 1	2/330 (0.61%)	0/256 (0.00%)	1/254 (0.39%)
Renal impairment * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Renal transplant * 1	2/330 (0.61%)	0/256 (0.00%)	1/254 (0.39%)
Renal vessel disorder * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Urinary incontinence * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Urinary tract disorder * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Urinary tract infection * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Reproductive system and breast disorders
Breast cancer * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
Epididymitis * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Ovarian cancer * 1	2/330 (0.61%)	2/256 (0.78%)	0/254 (0.00%)
Ovarian cyst * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Prostate examination abnormal * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Asbestosis * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Bronchitis * 1	3/330 (0.91%)	1/256 (0.39%)	0/254 (0.00%)
Bronchitis viral * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Dyspnoea * 1	9/330 (2.73%)	2/256 (0.78%)	2/254 (0.79%)
Pleural effusion * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Pneumonia * 1	10/330 (3.03%)	2/256 (0.78%)	1/254 (0.39%)
Pneumonia bacterial * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Sleep apnoea syndrome * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Skin and subcutaneous tissue disorders
Allergy to arthropod bite * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Cellulitis * 1	4/330 (1.21%)	2/256 (0.78%)	1/254 (0.39%)
Skin ulcer * 1	2/330 (0.61%)	1/256 (0.39%)	0/254 (0.00%)
Surgical and medical procedures
Limb operation * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Metatarsal excision * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Skin lesion excision * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Stent placement * 1	2/330 (0.61%)	0/256 (0.00%)	1/254 (0.39%)
Surgical vascular shunt * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Toe amputation * 1	5/330 (1.52%)	0/256 (0.00%)	0/254 (0.00%)
Vitrectomy * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Vascular disorders
Angioplasty * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Arterial occlusive disease * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Arteriosclerosis coronary artery * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Carotid artery occlusion * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Cerebrovascular accident * 1	7/330 (2.12%)	2/256 (0.78%)	1/254 (0.39%)
Coronary arterial stent insertion * 1	1/330 (0.30%)	0/256 (0.00%)	0/254 (0.00%)
Deep vein thrombosis * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Endarterectomy * 1	1/330 (0.30%)	0/256 (0.00%)	1/254 (0.39%)
Haematoma * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Iliac artery stenosis * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Pulmonary embolism * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Pulmonary oedema * 1	1/330 (0.30%)	1/256 (0.39%)	0/254 (0.00%)
Rectal haemorrhage * 1	2/330 (0.61%)	0/256 (0.00%)	0/254 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (11.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	69/330 (20.91%)	98/256 (38.28%)	163/254 (64.17%)
Blood and lymphatic system disorders
Anaemia * 1	21/330 (6.36%)	24/256 (9.38%)	13/254 (5.12%)
Hypercholesterolaemia * 1	11/330 (3.33%)	6/256 (2.34%)	13/254 (5.12%)
Cardiac disorders
Cardiac Failure Congestive * 1	19/330 (5.76%)	17/256 (6.64%)	14/254 (5.51%)
Hypertension * 1	17/330 (5.15%)	15/256 (5.86%)	21/254 (8.27%)
Eye disorders
Anterior Chamber Cell * 1	1/330 (0.30%)	14/256 (5.47%)	9/254 (3.54%)
Cataract * 1	38/330 (11.52%)	29/256 (11.33%)	57/254 (22.44%)
Cataract Cortical * 1	19/330 (5.76%)	22/256 (8.59%)	32/254 (12.60%)
Cataract Nuclear * 1	13/330 (3.94%)	30/256 (11.72%)	38/254 (14.96%)
Cataract Operation * 1	14/330 (4.24%)	16/256 (6.25%)	31/254 (12.20%)
Cataract Subcapsular * 1	29/330 (8.79%)	54/256 (21.09%)	75/254 (29.53%)
Conjunctival Hemorrhage * 1	7/330 (2.12%)	96/256 (37.50%)	105/254 (41.34%)
Diabetic Retinopathy * 1	12/330 (3.64%)	13/256 (5.08%)	5/254 (1.97%)
Dry Eye * 1	10/330 (3.03%)	13/256 (5.08%)	10/254 (3.94%)
Eye Irritation * 1	2/330 (0.61%)	12/256 (4.69%)	15/254 (5.91%)
Eye Pain * 1	11/330 (3.33%)	28/256 (10.94%)	33/254 (12.99%)
Eye Pruritus * 1	9/330 (2.73%)	14/256 (5.47%)	11/254 (4.33%)
Foreign body in the eye * 1	4/330 (1.21%)	61/256 (23.83%)	51/254 (20.08%)
Intraocular Pressure increased * 1	14/330 (4.24%)	50/256 (19.53%)	97/254 (38.19%)
Lacrimation increased * 1	9/330 (2.73%)	19/256 (7.42%)	16/254 (6.30%)
Maculopathy * 1	23/330 (6.97%)	31/256 (12.11%)	31/254 (12.20%)
Vision Blurred * 1	36/330 (10.91%)	44/256 (17.19%)	48/254 (18.90%)
Visual acuity reduced * 1	47/330 (14.24%)	40/256 (15.63%)	51/254 (20.08%)
Visual disturbance * 1	15/330 (4.55%)	23/256 (8.98%)	22/254 (8.66%)
Vitreous Detachment * 1	16/330 (4.85%)	13/256 (5.08%)	7/254 (2.76%)
Vitreous floaters * 1	36/330 (10.91%)	92/256 (35.94%)	98/254 (38.58%)
Vitrous Hemorrhage * 1	49/330 (14.85%)	43/256 (16.80%)	32/254 (12.60%)
General disorders
Dysonoea * 1	15/330 (4.55%)	13/256 (5.08%)	16/254 (6.30%)
Headache * 1	15/330 (4.55%)	11/256 (4.30%)	20/254 (7.87%)
Oedema peripheral * 1	14/330 (4.24%)	13/256 (5.08%)	8/254 (3.15%)
Renal and urinary disorders
Renal failure * 1	14/330 (4.24%)	13/256 (5.08%)	8/254 (3.15%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Adam R. Glassman, Director DRCR.net Coordinating Center
• Organization: Jaeb Center for Health Research
• Phone: 813-975-8690
• EMail: drcrnet@jaeb.org

Publications of Results:

Bhavsar AR, Ip MS, Glassman AR; DRCRnet and the SCORE Study Groups. The risk of endophthalmitis following intravitreal triamcinolone injection in the DRCRnet and SCORE clinical trials. Am J Ophthalmol. 2007 Sep;144(3):454-6. doi: 10.1016/j.ajo.2007.04.011.

Ip MS, Bressler SB, Antoszyk AN, Flaxel CJ, Kim JE, Friedman SM, Qin H; Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone and focal/grid photocoagulation for diabetic macular edema: baseline features. Retina. 2008 Jul-Aug;28(7):919-30. doi: 10.1097/IAE.0b013e31818144a7.

Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2008 Sep;115(9):1447-9, 1449.e1-10. doi: 10.1016/j.ophtha.2008.06.015. Epub 2008 Jul 26.

Diabetic Retinopathy Clinical Research Network (DRCR.net); Beck RW, Edwards AR, Aiello LP, Bressler NM, Ferris F, Glassman AR, Hartnett E, Ip MS, Kim JE, Kollman C. Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol. 2009 Mar;127(3):245-51. doi: 10.1001/archophthalmol.2008.610.

Aiello LP, Edwards AR, Beck RW, Bressler NM, Davis MD, Ferris F, Glassman AR, Ip MS, Miller KM; Diabetic Retinopathy Clinical Research Network. Factors associated with improvement and worsening of visual acuity 2 years after focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2010 May;117(5):946-53. doi: 10.1016/j.ophtha.2009.10.002. Epub 2010 Feb 1.

Bressler NM, Edwards AR, Beck RW, Flaxel CJ, Glassman AR, Ip MS, Kollman C, Kuppermann BD, Stone TW; Diabetic Retinopathy Clinical Research Network. Exploratory analysis of diabetic retinopathy progression through 3 years in a randomized clinical trial that compares intravitreal triamcinolone acetonide with focal/grid photocoagulation. Arch Ophthalmol. 2009 Dec;127(12):1566-71. doi: 10.1001/archophthalmol.2009.308.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.

Gangaputra S, Almukhtar T, Glassman AR, Aiello LP, Bressler N, Bressler SB, Danis RP, Davis MD; Diabetic Retinopathy Clinical Research Network. Comparison of film and digital fundus photographs in eyes of individuals with diabetes mellitus. Invest Ophthalmol Vis Sci. 2011 Aug 3;52(9):6168-73. doi: 10.1167/iovs.11-7321.

• Responsible Party: Jaeb Center for Health Research
• ClinicalTrials.gov Identifier: NCT00367133
• Other Study ID Numbers: NEI-105; U10EY018817-03 ( U.S. NIH Grant/Contract ); U10EY014229-07 ( U.S. NIH Grant/Contract ); U10EY014231-09 ( U.S. NIH Grant/Contract )
• First Submitted: August 3, 2006
• First Posted: August 22, 2006
• Results First Submitted: July 14, 2009
• Results First Posted: July 9, 2010
• Last Update Posted: August 26, 2016