CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 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/NCT02586727
NCT02586727Phase 2Completed
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Role of Intravitreal Aflibercept Injection for the Treatment of Radiation Maculopathy

Larkin Community Hospital·interventional·Posted Oct 26, 2015·Updated Oct 19, 2023

In Brief

A Phase 2 clinical trial evaluating aflibercept for Adverse Effect of Radiation Therapy. Completed, enrolled 40 participants.

Detailed Summary

The primary objective of the study is to assess the safety of intravitreal aflibercept injection in treating visually compromising radiation maculopathy secondary to treatment of uveal melanoma by iodione-125 brachytherapy. The study will consist of two arms of 25 patients each (totaling 50 patients). Subjects in arm 1 will undergo treatment every 6 weeks. Subjects in arm 2 will undergo treatment and if improvement is documented at the following evaluation the next treatment will be extended by two weeks. Secondary objectives of the study include evaluation and analysis of visual acuity, number of injections, macular edema, and vascular activity between both arms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdverse Effect of Radiation Therapy
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 26, 2015
Enrollment StartOct 1, 2015
Primary CompletionDec 1, 2018
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.7 years ago

Interventions

afliberceptdrug

This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward.