Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy

NCT ID: NCT01102946

Last Updated: 2011-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Diabetic Retinopathy Retinal Neovascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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PRP plus ranibizumab

Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab

Group Type EXPERIMENTAL

Panretinal Photocoagulation

Intervention Type PROCEDURE

Panretinal photocoagulation with green laser according to ETDRS

Ranibizumab

Intervention Type DRUG

Ranibizumab (Lucentis), intravitreal injections of 0.05ml

PRP

Patients will only be submitted to panretinal photocoagulation

Group Type ACTIVE_COMPARATOR

Panretinal Photocoagulation

Intervention Type PROCEDURE

Panretinal photocoagulation with green laser according to ETDRS

Interventions

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Panretinal Photocoagulation

Panretinal photocoagulation with green laser according to ETDRS

Intervention Type PROCEDURE

Ranibizumab

Ranibizumab (Lucentis), intravitreal injections of 0.05ml

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of São Paulo

Locations

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University of São Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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Other Identifiers

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IRaHi

Identifier Type: -

Identifier Source: org_study_id

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