Prospective, Randomized, Multicentre, Open-label, Phase II / III Study to Assess Efficacy and Safety of Ranibizumab 0.5 mg Intravitreal Injections Plus Panretinal Photocoagulation (PRP) Versus PRP in Monotherapy in the Treatment of Subjects With High Risk Proliferative Diabetic Retinopathy.

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

April 30, 2016

Study Completion Date

October 31, 2017

Conditions
High Risk Proliferative Diabetic Retinopathy
Interventions
PROCEDURE

Panretinal Photocoagulation (PRP)

DRUG

Intravitreous injection of ranibizumab

Trial Locations (13)

20132

Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffael, Milan

21033

Department of Ophthalmology, University Hospital, CHU Dijon, Dijon

35128

Centre for Clinical Trials, Department of Ophthalmology, University of Padova, Padua

75475

Department of Ophthalmology, Lariboisière Hospital, Paris

75571

Centre d'Investigation Clinique - Centre National d'Ophtalmologie des Quinze-Vingts, Paris

00198

G.B.Bietti Eye Foundation - IRCCS, Rome

3000-548

Centre for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image, Coimbra

3030-163

Espaço Médico de Coimbra, Coimbra

1050-085

Instituto de Retina de Lisboa, Lisbon

2600-009

Serviço de Oftalmologia,Hospital de Vila Franca de Xira, Vila Franca de Xira

GU16 7UJ

Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust, Frimley

GL53 7PX

Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust, Gloucestershire

SE5 9RS

Laser and Retinal Research Unit, King's Health Partners, London

All Listed Sponsors
collaborator

European Vision Institute Clinical Research Network

NETWORK

lead

Association for Innovation and Biomedical Research on Light and Image

OTHER