Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy

Sponsor
University of Sao Paulo
Study ID
NCT01102946
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Ranibizumab (Lucentis), intravitreal injections of 0.05ml
  • Panretinal Photocoagulation — PROCEDURE
    Panretinal photocoagulation with green laser according to ETDRS

Study Details

The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.

Key Dates

First listed
Apr 13, 2010
Start date
Feb 28, 2009
Status verified
Jan 2011
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PRP plus ranibizumab
    Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab
  • Active Comparator: PRP
    Patients will only be submitted to panretinal photocoagulation

Primary Outcome Measure

Fluorescein leakage area (mm2) [ Time Frame: Week 48 after inclusion in the study ]

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