Diabetic Retinopathy, Retinal Neovascularization
Conditions
Keywords
proliferative diabetic retinopathy, retinal neovascularization, Angiogenesis Inhibitors, ranibizumab, laser
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.
Interventions
DRUGRanibizumab
Ranibizumab (Lucentis), intravitreal injections of 0.05ml
PROCEDUREPanretinal Photocoagulation
Panretinal photocoagulation with green laser according to ETDRS
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescein leakage area (mm2) | Week 48 after inclusion in the study | Neovascularization area measured during fluorescein agiography middle phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CMT | Week 48 after inclusion in the study | Macular thickness measured with Stratus OCT protocols |
| LogMAR BCVA | Week 48 after inclusion in the study | LogMAR best corrected visual acuity measured with ETDRS charts |
| 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 | — |
Countries
Brazil
Outcome results
None listed