A Phase 2 interventional study of Ranibizumab and Panretinal Photocoagulation in Diabetic Retinopathy and Retinal Neovascularization, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-08-04.
Sponsored by University of Sao Paulo · Phase 2, Interventional, and Treatment
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.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab
Drug: Ranibizumab · Procedure: Panretinal Photocoagulation
Patients will only be submitted to panretinal photocoagulation
Procedure: Panretinal Photocoagulation
Ranibizumab (Lucentis), intravitreal injections of 0.05ml
Also known as: Lucentis
Panretinal photocoagulation with green laser according to ETDRS
Fluorescein leakage area (mm2)
Neovascularization area measured during fluorescein agiography middle phase
Time frame: Week 48 after inclusion in the study
CMT
Macular thickness measured with Stratus OCT protocols
Time frame: Week 48 after inclusion in the study
LogMAR BCVA
LogMAR best corrected visual acuity measured with ETDRS charts
Time frame: Week 48 after inclusion in the study
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
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo