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Prospective, Randomized, Multicenter, Open Label, Phase II Study to Access Efficacy and Safety of Lucentis® Monotherapy Compared With Lucentis® Plus Panretinal Photocoagulation (PRP) and PRP in the Treatment of Patients With High Risk Proliferative Diabetic Retinopathy

NCT01280929 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-10-08

No results posted yet for this study

Summary

The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation alone in the regression of retinal neovascularization in eyes with high-risk proliferative diabetic retinopathy.

Conditions

  • High Risk Proliferative Diabetic Retinopathy

Interventions

PROCEDURE

Panretinal Photocoagulation (PRP)

DRUG

Intravitreous injection of ranibizumab

Sponsors & Collaborators

  • José Cunha-Vaz

    lead OTHER

Principal Investigators

  • José Cunha-Vaz, MD, PhD · Association for Innovation and Biomedical Research on Light and Image

  • João Figueira, MD · Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Portugal

Study Locations

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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 NCT01280929 on ClinicalTrials.gov