CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Afliberceptdrug
Likely dose
Aflibercept 2mgfrom 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/NCT02661711
NCT02661711Phase 2Completed
CompareCT.gov

Prospective Non-randomised Exploratory Study to Assess the Safety and Efficacy of Aflibercept (Eylea) in Cystoid Macular Oedema (CMO) Associated With Retinitis Pigmentosa (RP)

Moorfields Eye Hospital NHS Foundation Trust·interventional·Posted Jan 22, 2016·Updated May 6, 2024

In Brief

A Phase 2 clinical trial evaluating Aflibercept for Macular Oedema and Retinitis Pigmentosa. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the safety and efficacy of intravitreal injections of Aflibercept (Eylea) in treating Cystoid Macula Oedema (CMO) in patients with underlying Retinitis Pigmentosa (RP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Oedema, Retinitis Pigmentosa
CountriesUnited Kingdom
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 22, 2016
Enrollment StartMar 1, 2016
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.4 years ago

Interventions

Afliberceptdrug

2mg of 40mg/ml of Eylea Solution administered via intravitreal injection every four weeks for three months (loading dose), followed by a treat and extend protocol up to 12 months. Extension from monthly to 6, 8, 10 and 12 week follow up will occur where there is no reduction in macula oedema compared with the previous visit. Number of cycles; minimum of 5 injections and maximum of 13 injections per study eye.