CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 305 enrolled
Drug / intervention
0.5-mg Ranibizumab +2 moredrug
Likely dose
0.5-mg 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/NCT01489189
NCT01489189Phase 3Completed
CompareCT.gov

Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Jaeb Center for Health Research·interventional·Posted Dec 9, 2011·Updated Oct 29, 2021

In Brief

A Phase 3 clinical trial evaluating Prompt Panretinal Photocoagulation, 0.5-mg Ranibizumab, and 1 other intervention for Proliferative Diabetic Retinopathy. Completed, enrolled 305 participants across 48 sites.

Detailed Summary

The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy. Secondary objectives include: * Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP. * Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP. * Comparing safety outcomes between treatment groups. * Comparing associated treatment and follow-up exam costs between treatment groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProliferative Diabetic Retinopathy
CountriesUnited States
CollaboratorsNational Eye Institute (NEI), Genentech, Inc.

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2011
Enrollment StartMar 1, 2012
Primary CompletionJan 1, 2015
Study CompletionFeb 5, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.6 years ago

Interventions

Prompt Panretinal Photocoagulationother

Panretinal photocoagulation alone at baseline (full session completed within 56 days).

0.5-mg Ranibizumabdrug

Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.

Deferred panretinal photocoagulationother

PRP is deferred until failure/futility criteria for intravitreal injection are met.