CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 333 enrolled
Drug / intervention
Ranibizumab +3 moredrug
Likely dose
Ranibizumab 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00445003
NCT00445003Phase 3Completed

Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Jaeb Center for Health Research·interventional·Posted Mar 8, 2007·Updated Aug 26, 2016

In Brief

A Phase 3 clinical trial evaluating Ranibizumab, Triamcinolone Acetonide, and 2 other interventions for Proliferative Diabetic Retinopathy and Diabetic Macular Edema. Completed, enrolled 333 participants across 56 sites.

Detailed Summary

The purpose of the study is to find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections are beneficial in preventing vision loss after panretinal photocoagulation (PRP) treatment. It is possible that one or both of the types of injections will prevent vision loss after PRP treatment. However, it is not known whether the benefits of the injections will outweigh the risks. It is possible that because of side effects, the injections may not be as good as laser alone in treating the diabetic retinopathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 8, 2007
Enrollment StartMar 1, 2007
Primary CompletionOct 1, 2009
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 19.3 years ago

Interventions

Ranibizumabdrug

Intravitreal injection of 0.5 mg ranibizumab at baseline and 4 weeks

Triamcinolone Acetonidedrug

Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks

Sham injectionbehavioral

Sham injection at baseline and 4 weeks

Focal/grid laserprocedure

Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.