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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 (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00367133
First received: August 3, 2006
Last updated: August 25, 2016
Last verified: August 2016
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
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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 
[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.
Visual Acuity Categorized by Randomization Strata [1] 
[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 
[1] Letter score and approximate Snellen equivalent. Best score is 97, worst is 0.
Central subfield thickness on OCT [1] 
[Units: Microns]
Median (Inter-Quartile Range)
 398 
 (329 to 505) 
 405 
 (327 to 514) 
 396 
 (323 to 484) 
 400 
 (323 to 514) 
[1] 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 
[Units: Years]
Median (Inter-Quartile Range)
 15 
 (9 to 21) 
 15 
 (9 to 21) 
 16 
 (10 to 22) 
 15 
 (9 to 22) 
HbA1c [1] 
[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) 
[1] Missing HbA1c data in 64, 46, and 50 in the laser, 1 mg, and 4 mg groups respectively
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 [1] 
[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) 
[1] 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] 
[Units: Letter Score]
Median (Inter-Quartile Range)
 62 
 (53 to 67) 
 62 
 (54 to 67) 
 62 
 (52 to 67) 
 62 
 (52 to 67) 
[1] 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
  Show All Outcome Measures

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 ]

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

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

4.  Secondary:   Central Subfield Thickness at 2 Years   [ Time Frame: 2 Years ]

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

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

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

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

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

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

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

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

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

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

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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.


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:

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

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00367133     History of Changes
Other Study ID Numbers: NEI-105
U10EY018817-03 ( US NIH Grant/Contract Award Number )
U10EY014229-07 ( US NIH Grant/Contract Award Number )
U10EY014231-09 ( US NIH Grant/Contract Award Number )
Study First Received: August 3, 2006
Results First Received: July 14, 2009
Last Updated: August 25, 2016
Health Authority: United States: Food and Drug Administration