Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy

Phase 2

Completed

• Conditions: Diabetic Retinopathy; Retinal Neovascularization
• Interventions: Drug: Ranibizumab; Procedure: Panretinal Photocoagulation

• Registration Number: NCT01102946
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Status Verified: 2011-01
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-08-03
• Last Update Posted: 2011-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age ≥ 18 years old
• High risk proliferative diabetic retinopathy
• Visual acuity ≥ 20/800
• No previous laser treatment for diabetic retinopathy

Exclusion Criteria

• Previous pars plana vitrectomy
• Systemic thrombo-embolic events
• Uncontrolled systemic hypertension
• Conditions avoiding adequated documentation
• Previous eye surgery in the last 6 months before inclusion in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP plus ranibizumab	Panretinal Photocoagulation	Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab
PRP	Panretinal Photocoagulation	Patients will only be submitted to panretinal photocoagulation
PRP plus ranibizumab	Ranibizumab	Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab

Primary Outcome Measures

Name	Time	Method
Fluorescein leakage area (mm2)	Week 48 after inclusion in the study	Neovascularization area measured during fluorescein agiography middle phase

Secondary Outcome Measures

Name	Time	Method
Rod pathway integrity and oscillatory potential amplitudes	Week 48 after inclusion in the study
LogMAR BCVA	Week 48 after inclusion in the study	LogMAR best corrected visual acuity measured with ETDRS charts
CMT	Week 48 after inclusion in the study	Macular thickness measured with Stratus OCT protocols
Retina mid periphery visual field sensitivity change	Week 48 after inclusion in the study

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 Ribeirao Preto, Sao Paulo, Brazil