Clinical Trial: Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: University of Sao Paulo

Current Primary Outcome: Fluorescein leakage area (mm2) [ Time Frame: Week 48 after inclusion in the study ]

Neovascularization area measured during fluorescein agiography middle phase


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • CMT [ Time Frame: Week 48 after inclusion in the study ]
    Macular thickness measured with Stratus OCT protocols
  • LogMAR BCVA [ Time Frame: Week 48 after inclusion in the study ]
    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 ]
  • Rod pathway integrity and oscillatory potential amplitudes [ Time Frame: Week 48 after inclusion in the study ]


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: April 9, 2010
Date Started: February 2009
Date Completion:
Last Updated: August 3, 2011
Last Verified: January 2011