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

This study has been completed.
Sponsor:
Collaborators:
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
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  
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: cubicĀ 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: LetterĀ 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
  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


  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:

Publications automatically indexed to this study:

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