CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Aflibercept +1 moredrug
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/NCT02299336
NCT02299336Phase 4Completed
CompareCT.gov

Long-Term Efficacy and Safety of Intravitreal Aflibercept Injections for the Treatment of Diabetic Macular Edema in Subjects Who Completed the Three Year VISTA-DME Trial .

Greater Houston Retina Research·interventional·Posted Nov 24, 2014·Updated Jun 4, 2019

In Brief

A Phase 4 clinical trial evaluating Aflibercept and Focal Laser for Diabetic Macular Edema. Completed, enrolled 60 participants across 3 sites.

Detailed Summary

The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009; NCT01363440) end-point. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesUnited States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 24, 2014
Enrollment StartNov 24, 2014
Primary CompletionJan 9, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.6 years ago

Interventions

Afliberceptdrug

pro re nata (PRN)

Focal Laserprocedure

Focal laser administered based on pre-specified criteria