Trial intelligence / Profile preview

PROPER: Macular Perfusion in PDR

NCT04674254Phase 4

Key facts

Status: Completed
Start: Mar 2021
Primary completion: Mar 2023
Countries: 1
Sponsor: Cairo University
Modality: Monoclonal Antibodies

Drugs: bevacizumab
Conditions: proliferative diabetic retinopathy (PDR)

Overview

Phase 4, randomised, open-label trial of bevacizumab in proliferative diabetic retinopathy (PDR) (3 arms), sponsored by Cairo University. Primary endpoints: Change in foveal avascular zone area at 12 months and Change in vascular density of the retinal capillary plexuses at 12 months. Started Mar 2021; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

Anti-VEGF (Bevacizumab)
Intravitreal Bevacizumab 1.25mg
Targeted Retinal Photocoagulation
Laser to non-perfused areas
Standard Pan-retinal Photocoagulation
Standard PRP laser

Who it enrols

Adult patients with Type 1 or 2 diabetes and proliferative diabetic retinopathy (PDR) without diabetic macular edema (CMT < 300 µm), who have not received prior retinal laser treatment or DME therapy.

Endpoints

Primary

Change in foveal avascular zone area12 months
Change in vascular density of the retinal capillary plexuses12 months

Secondary

Change in neovessels12 months
Change in central macular thickness12 months
Change in best corrected visual acuity12 months
Change in macular sensitivity12 months
Change in orbital blood flow12 months

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