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

This study has been completed.

Sponsor:

Collaborators:

National Eye Institute (NEI)

Allergan

Information provided by:

Diabetic Retinopathy Clinical Research Network

ClinicalTrials.gov Identifier:

NCT00367133

First received: August 3, 2006

Last updated: March 18, 2011

Last verified: March 2011

History of Changes

Results First Received: July 14, 2009

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

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eighty-eight academic and community based sites across the United States recruited 693 subjects from May 2004 to July 2006.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Focal/Grid Laser Photocoagulation	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1mg Intravitreal Triamcinolone	Intravitreal injection of 1mg of triamcinolone acetonide
4 mg Intravitreal Triamcinolone	Intravitreal injection of 4mg of triamcinolone acetonide

Participant Flow for 2 periods

Period 1: 2 Years

	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
STARTED	330 ^[1]	256 ^[1]	254 ^[1]
COMPLETED	272	220	205
NOT COMPLETED	58	36	49
Death	20	12	12
Dropped	34	19	33
Missed visit	4	5	4

[1]	Number of Eyes

Period 2: 3 Years

	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone
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

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Reporting Groups

	Description
Focal/Grid Laser Photocoagulation	Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1mg Intravitreal Triamcinolone	Intravitreal injection of 1mg of triamcinolone acetonide
4 mg Intravitreal Triamcinolone	Intravitreal injection of 4mg of triamcinolone acetonide
Total	Total of all reporting groups

Baseline Measures

	Focal/Grid Laser Photocoagulation	1mg Intravitreal Triamcinolone	4 mg Intravitreal Triamcinolone	Total
Number of Participants [units: participants]	330	256	254	840
Age [units: years] Median ( Inter-Quartile Range )	63 ( 57 to 69 )	63 ( 58 to 70 )	63 ( 57 to 69 )	63 ( 57 to 70 )
Gender [units: participants]
Female	166	120	125	411
Male	164	136	129	429
Race/Ethnicity, Customized [units: 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 [units: Participants]
Type 1	14	12	12	38
Type 2	316	244	242	802
History of ocular hypertension [units: Eyes]
Ocular Hypertension	3	8	4	15
No Ocular Hypertension	327	248	250	825
Lens status phakic (clinical examination) [units: Eyes]
Phakic	262	203	197	662
Pseudophakic	68	53	57	178
OCT cystoid abnormality (questionable or definite) [units: Eyes]
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 [units: Eyes]
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 [units: Eyes]
Prior Panretinal scatter photocoagulation	53	40	42	135
No Prior Panretinal scatter photocoagulation	277	216	212	705
Prior photocoagulation for diabetic macular edema [units: Eyes]
Prior photocoagulation for DME	198	154	158	510
No Prior photocoagulation for DME	132	102	96	330
Retinopathy severity (ETDRS severity scale) ^[1] [units: Eyes]
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
Visual Acuity Categorized by Randomization Strata ^[2] [units: Eyes]
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
Central subfield thickness on OCT ^[3] [units: Microns] Median ( Inter-Quartile Range )	398 ( 329 to 505 )	405 ( 327 to 514 )	396 ( 323 to 484 )	400 ( 323 to 514 )
Duration of Diabetes [units: Years] Median ( Inter-Quartile Range )	15 ( 9 to 21 )	15 ( 9 to 21 )	16 ( 10 to 22 )	15 ( 9 to 22 )
HbA1c ^[4] [units: Percentage] Median ( Inter-Quartile Range )	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 )
Intraocular pressure [units: microns] Median ( Inter-Quartile Range )	16 ( 13 to 18 )	16 ( 13 to 18 )	16 ( 14 to 18 )	16 ( 13 to 18 )
Retinal volume on OCT ^[5] [units: cubic millimetre] Median ( Inter-Quartile Range )	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 )
e-ETDRS visual acuity ^[6] [units: Letter Score] Median ( Inter-Quartile Range )	62 ( 53 to 67 )	62 ( 54 to 67 )	62 ( 52 to 67 )	62 ( 52 to 67 )

[1]	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.
[2]	Letter score and approximate Snellen equivalent. Best score is 97, worst is 0.
[3]	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.
[4]	Missing HbA1c data in 64, 46, and 50 in the laser, 1 mg, and 4 mg groups respectively
[5]	Missing/ungradeable optical coherence tomography and fundus photo data for the laser, 1mg, and 4 mg groups respectively: 37, 36, 48.
[6]	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

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1. Primary:

Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years. [ Time Frame: Baseline to 2 Years ]

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2. Primary:

Median Change in Visual Acuity Baseline to 2 Years [ Time Frame: Baseline to 2 Years ]

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3. Primary:

Distribution of Change in Visual Acuity Baseline to 2 Years [ Time Frame: baseline to 2 years ]

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4. Secondary:

Central Subfield Thickness at 2 Years [ Time Frame: 2 Years ]

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5. Secondary:

Mean Change in Central Subfield Thickness Baseline to 2 Years [ Time Frame: Baseline to 2 years ]

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6. Secondary:

Median Change in Central Subfield Thickness Baseline to 2 Years [ Time Frame: Baseline to 2 Years ]

Show Outcome Measure 6

7. Secondary:

Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years [ Time Frame: Baseline to 2 Years ]

Show Outcome Measure 7

8. Secondary:

Central Subfield Thickness < 250 Microns at 2 Years [ Time Frame: 2 Years ]

Show Outcome Measure 8

9. Secondary:

Change in Visual Acuity From Baseline to 3 Years [ Time Frame: Baseline to 3 year ]

Show Outcome Measure 9

10. Secondary:

Change in Visual Acuity From Baseline to 3 Years [ Time Frame: Baseline to 3 year ]

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11. Secondary:

Distribution of Visual Acuity Change Baseline to 3 Years [ Time Frame: Baseline to 3 years ]

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12. Secondary:

Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years [ Time Frame: 3 years ]

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13. Secondary:

Change in Central Subfield Thickness on OCT Baseline to 3 Years [ Time Frame: Baseline to 3 years ]

Show Outcome Measure 13

14. Secondary:

Change in Central Subfield Thickness on OCT Baseline to 3 Years [ Time Frame: baseline to 3 years ]

Show Outcome Measure 14

15. Secondary:

Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years [ Time Frame: Baseline to 3 years ]

Show Outcome Measure 15

Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Adam R. Glassman, Director DRCR.net Coordinating Center
Organization: Jaeb Center for Health Research
phone: 813-975-8690
e-mail: 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.

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.

Diabetic Retinopathy Clinical Research Network. A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Focal/Grid Photocoagulation for Diabetic Macular Edema. Ophthalmology. 2008 Jul 26; [Epub ahead of print]

Diabetic Retinopathy Clinical Research Network (DRCR.net). 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.

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. 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.

Publications automatically indexed to this study:

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. Print 2011 Aug.

Responsible Party:	Roy W. Beck, M.D., Ph.D., Director, Jaeb Center for Health Research (DRCR.net)
ClinicalTrials.gov Identifier:	NCT00367133 History of Changes
Other Study ID Numbers:	NEI-105, U10EY018817-03, U10EY014229-07, U10EY014231-09
Study First Received:	August 3, 2006
Results First Received:	July 14, 2009
Last Updated:	March 18, 2011
Health Authority:	United States: Food and Drug Administration

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