Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema (LRT for DME)

This study has been completed.
Sponsor:
Collaborators:
Allergan
Genentech
Information provided by (Responsible Party):
Diabetic Retinopathy Clinical Research Network
ClinicalTrials.gov Identifier:
NCT00444600
First received: March 6, 2007
Last updated: April 7, 2014
Last verified: April 2014
Results First Received: January 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetic Retinopathy
Diabetic Macular Edema
Interventions: Drug: Triamcinolone Acetonide + laser
Drug: Ranibizumab + laser
Drug: Sham injection + laser
Drug: Ranibizumab + deferred laser

  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
Fifty two academic and community based sites across the United States recruited 691 study participants from March 2007 to December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.

Reporting Groups
  Description
Sham+Prompt Laser Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
0.5 mg Ranibizumab+Prompt Laser 0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
0.5 mg Ranibizumab+Deferred Laser 0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
4 mg Triamcinolone+Prompt Laser 4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.

Participant Flow:   Overall Study
    Sham+Prompt Laser     0.5 mg Ranibizumab+Prompt Laser     0.5 mg Ranibizumab+Deferred Laser     4 mg Triamcinolone+Prompt Laser  
STARTED     293 [1]   187 [1]   188 [1]   186 [1]
COMPLETED     274 [1]   171 [1]   178 [1]   176 [1]
NOT COMPLETED     19     16     10     10  
Death                 7                 5                 3                 2  
Dropped                 11                 11                 7                 7  
Missed visit                 1                 0                 0                 1  
[1] Number of eyes



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity   [ Time Frame: from baseline to 1 Year ]

2.  Primary:   Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year   [ Time Frame: from baseline to 1 Year ]

3.  Primary:   Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline   [ Time Frame: from baseline to 1 Year ]

4.  Primary:   Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema   [ Time Frame: from baseline to 1 Year ]

5.  Primary:   Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score   [ Time Frame: from baseline to 1 Year ]

6.  Primary:   Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness   [ Time Frame: from baseline to 1 Year ]

7.  Primary:   Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity   [ Time Frame: from baseline to 1 Year ]

8.  Primary:   Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator   [ Time Frame: from baseline to 1 Year ]

9.  Secondary:   Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year   [ Time Frame: from baseline to 1 year ]

10.  Secondary:   Number of Injections in First Year   [ Time Frame: from baseline to 1 year ]

11.  Secondary:   Number of Laser Treatments Received Prior to the 1 Year Visit   [ Time Frame: 1 Year ]

12.  Secondary:   Percentage of Eyes Receiving Laser at the 48 Week Visit (%)   [ Time Frame: 1 Year ]

13.  Secondary:   Mean Optical Coherence Tomography Retinal Volume at 1 Year   [ Time Frame: 1 Year ]

14.  Secondary:   Mean Change in Optical Coherence Tomography Retinal Volume From Baseline to 1 Year   [ Time Frame: from baseline to 1 Year ]

15.  Other Pre-specified:   Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year   [ Time Frame: 1 Year ]

16.  Other Pre-specified:   Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening   [ Time Frame: 1 Year ]

17.  Other Pre-specified:   Eyes With Alternative Treatments Prior to the 1-year Visit   [ Time Frame: 1 Year ]

18.  Other Pre-specified:   Change From Moderately Severe Non-proliferative Diabetic Retinopathy or Better From Baseline to 1-year   [ Time Frame: from baseline to 1 Year ]

19.  Other Pre-specified:   Change From Severe Non-proliferative Diabetic Retinopathy or Worse From Baseline to 1-year   [ Time Frame: from baseline to 1 Year ]

20.  Other Pre-specified:   Cardiovascular Events According to Antiplatelet Trialists' Collaboration Through 1 Year   [ Time Frame: 1 Year ]

21.  Other Pre-specified:   Major Ocular Adverse Events During First Year of Follow-Up   [ Time Frame: 1 Year ]


  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
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