MedTrace Logo

Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study

NCT02661711 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-05-06

Study results available
· View outcomes & findings →

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).

Conditions

Interventions

DRUG

Aflibercept

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.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Moorfields Eye Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Michel Michaelides, Professor · Moorfields Eye Hospital, Institute of Ophthalmology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02661711 on ClinicalTrials.gov