Panretinal Photocoagulation Versus Panretinal Photocoagulation Plus Intravitreous Ranibizumab for High Risk Proliferative Diabetic Retinopathy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Fluorescein leakage area (mm2)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PRP plus ranibizumab
Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab
Intervention: Ranibizumab (Drug)
PRP plus ranibizumab
Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab
Intervention: Panretinal Photocoagulation (Procedure)
PRP
Patients will only be submitted to panretinal photocoagulation
Intervention: Panretinal Photocoagulation (Procedure)
Outcomes
Primary Outcomes
Fluorescein leakage area (mm2)
Time Frame: Week 48 after inclusion in the study
Neovascularization area measured during fluorescein agiography middle phase
Secondary Outcomes
- CMT(Week 48 after inclusion in the study)
- LogMAR BCVA(Week 48 after inclusion in the study)
- Retina mid periphery visual field sensitivity change(Week 48 after inclusion in the study)
- Rod pathway integrity and oscillatory potential amplitudes(Week 48 after inclusion in the study)