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Completed

NCT Number: NCT01102946

Panretinal Photocoagulation (PRP) Plus Ranibizumab for 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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Diseases Retinal Neovascularization Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of São Paulo

Ribeirão Preto, São Paulo, 14048-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

Ranibizumab (Lucentis), intravitreal injections of 0.05ml

Other names: Lucentis

Panretinal Photocoagulation

Procedure

Panretinal photocoagulation with green laser according to ETDRS

Primary outcomes

  1. Fluorescein leakage area (mm2)

    Time frame: Week 48 after inclusion in the study

    Neovascularization area measured during fluorescein agiography middle phase

Secondary outcomes

  1. CMT

    Time frame: Week 48 after inclusion in the study

    Macular thickness measured with Stratus OCT protocols

  2. LogMAR BCVA

    Time frame: Week 48 after inclusion in the study

    LogMAR best corrected visual acuity measured with ETDRS charts

  3. Retina mid periphery visual field sensitivity change

    Time frame: Week 48 after inclusion in the study

  4. Rod pathway integrity and oscillatory potential amplitudes

    Time frame: Week 48 after inclusion in the study

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: IRaHi

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 13, 2010
Registry last updated
Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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