Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To investigate the effectiveness of intravitreal applications of 0.5 mg Lucentis
(ranibizumab) in patients with vitreous hemorrhage due to proliferative diabetic retinopathy.
The primary endpoint for the study will be the mean change in best-corrected visual acuity
(BCVA) from baseline to the mean level at Month 3.
Secondary Objectives:
1. To assess any differences in mean change in BCVA over time;
2. To assess differences in vitreous transparency (amount of hemorrhage) with fundus
angiography exam;
3. To assess any differences in retinopathy severity level according to the Early Treatment
Diabetic Retinopathy Study;
4. To correlate the visual outcomes with serum glucose levels.
Phase:
Phase 4
Details
Lead Sponsor:
Hospital Regional de São José - Dr. Homero de Miranda Gomes