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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01102946
First received: April 9, 2010
Last updated: August 3, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Diabetic Retinopathy
Retinal Neovascularization
Drug: Ranibizumab
Procedure: Panretinal Photocoagulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Panretinal Photocoagulation Versus Panretinal Photocoagulation Plus Intravitreous Ranibizumab for High Risk Proliferative Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Fluorescein leakage area (mm2) [ Time Frame: Week 48 after inclusion in the study ] [ Designated as safety issue: No ]
    Neovascularization area measured during fluorescein agiography middle phase


Secondary Outcome Measures:
  • CMT [ Time Frame: Week 48 after inclusion in the study ] [ Designated as safety issue: No ]
    Macular thickness measured with Stratus OCT protocols

  • LogMAR BCVA [ Time Frame: Week 48 after inclusion in the study ] [ Designated as safety issue: No ]
    LogMAR best corrected visual acuity measured with ETDRS charts

  • Retina mid periphery visual field sensitivity change [ Time Frame: Week 48 after inclusion in the study ] [ Designated as safety issue: No ]
  • Rod pathway integrity and oscillatory potential amplitudes [ Time Frame: Week 48 after inclusion in the study ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102946

Locations
Brazil
University of São Paulo
Ribeirao Preto, Sao Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Rodrigo Jorge, University of São Paulo
ClinicalTrials.gov Identifier: NCT01102946     History of Changes
Other Study ID Numbers: IRaHi
Study First Received: April 9, 2010
Last Updated: August 3, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
proliferative diabetic retinopathy
retinal neovascularization
Angiogenesis Inhibitors
ranibizumab
laser

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Neovascularization, Pathologic
Retinal Neovascularization
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014