Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy (IRaHi)

August 3, 2011 updated by: University of Sao Paulo

Panretinal Photocoagulation Versus Panretinal Photocoagulation Plus Intravitreous Ranibizumab for High Risk Proliferative Diabetic Retinopathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Ribeirao Preto, Sao Paulo, Brazil, 14048-900
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP plus ranibizumab
Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab
Drug: Ranibizumab
Ranibizumab (Lucentis), intravitreal injections of 0.05ml
Other Names:
  • Lucentis
Procedure: Panretinal Photocoagulation
Panretinal photocoagulation with green laser according to ETDRS
Active Comparator: PRP
Patients will only be submitted to panretinal photocoagulation
Procedure: Panretinal Photocoagulation
Panretinal photocoagulation with green laser according to ETDRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluorescein leakage area (mm2)
Time Frame: Week 48 after inclusion in the study
Neovascularization area measured during fluorescein agiography middle phase
Week 48 after inclusion in the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRaHi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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