CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Afliberceptdrug
Likely dose
Aflibercept intravitreal injectionAI-extracted
Key inclusion· 4
  • Type 1 or type 2 diabetes mellitus
  • Best-corrected visual acuity better than 20/400 in study eye
  • Substantial retinal non-perfusion (>20 disc areas) by investigator assessment
  • Early proliferative diabetic retinopathy without vitreous hemorrhage; PRP can safely be deferred
Key exclusion· 11
  • Any prior systemic or intravitreal anti-VEGF treatment in study eye
  • Central retinal thickness >320 µm on SD-OCT
  • Evidence of infectious ocular infection at screening
  • History of vitreoretinal surgery in study eye

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

Search/NCT02863354
NCT02863354Phase 2Completed

Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy

Charles C Wykoff, PhD, MD·interventional·Posted Aug 11, 2016·Updated May 24, 2021

In Brief

A Phase 2 clinical trial evaluating Aflibercept for Proliferative Diabetic Retinopathy. Completed, enrolled 43 participants across 4 sites.

Detailed Summary

The RECOVERY trial will assess the safety and tolerability of 2 mg intravitreal aflibercept injections (IAI) given monthly (Q4WK) or every 12 weeks (Q12WK) for the treatment of retinal capillary non-perfusion (RNP) associated with proliferative diabetic retinopathy (PDR). * Assess the safety and tolerability of IAI for the treatment of proliferative diabetic retinopathy by evaluating the incidence and severity of ocular and systemic adverse events through week 52 * Change in area of retinal capillary non-perfusion, as assessed by central reading center, from baseline through week 52

Study Details

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

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 11, 2016
Enrollment StartAug 1, 2016
Primary CompletionMay 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.9 years ago

Interventions

Afliberceptdrug

Intravitreal injection