CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
Afliberceptdrug
Likely dose
Not stated in 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/NCT02503540
NCT02503540Phase 4Completed
CompareCT.gov

Peripheral and Macular Retinal Vascular Perfusion and Leakage Dynamics in Diabetic Macular Edema and Retinal Venous Occlusions During Intravitreal Aflibercept Injection (IAI) Treatment for Retinal Edema: PERMEATE Study

Justis Ehlers·interventional·Posted Jul 21, 2015·Updated May 12, 2021

In Brief

A Phase 4 clinical trial evaluating Aflibercept for Retinal Vein Occlusion and 3 related conditions. Completed, enrolled 31 participants across 1 site.

Detailed Summary

This interventional study will evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein angiography and optical coherence tomography (OCT) angiography will be performed at multiple timepoints to assess the changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the study duration and compare these alterations to baseline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinal Vein Occlusion, Diabetic Macular Edema, Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion
CountriesUnited States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 21, 2015
Enrollment StartAug 18, 2015
Primary CompletionFeb 6, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.9 years ago

Interventions

Afliberceptdrug

Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.