drugset / Trial / NCT01824043

Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage

NCT01824043

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-03
Primary completion
2013-09
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 0.5 mg Intravitreal