Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage

Diabetic Retinopathy Clinical Trial

Official title: Pilot Study Investigating the Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage in Proliferative Diabetic Retinopathy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Written informed consent must be obtained before any study assessment is performed.

This study will have only one group of patients, with a total of twenty subjects stratified based on decreased visual acuity due to vitreous hemorrhage in proliferative diabetic retinopathy:

Stratus 1 (ten subjects): patients with low to moderate diabetic vitreous hemorrhage; Stratus 2 (ten subjects): patients with severe diabetic vitreous hemorrhage. Patients will be treated monthly: intravitreal ranibizumab (0.5 mg) will be administered in an open-label fashion, using 3 monthly injections (at day 0, day 30 and day 60) followed by an additional post treatment visit, a month after the last injection, for posterior reports.

During regular, monthly visits, a detailed ophthalmologic evaluation will be performed, including a BCVA assessment. Vitreous hemorrhage density will also be assessed, according to the fundus visualization in retinal angiography:

1. low to moderate vitreous hemorrhage: posterior pole detail slightly hazy or very hazy;

2. severe vitreous hemorrhage: fundus details not visible. All patients with severe vitreous hemorrhage will have A/B ultrasound scan performed in the day of the injection. The intravitreal injection will always be the last procedure performed in a given day.

Blood samples will also be collected in each study visit, in order to assess serum glucose levels.

Laser treatment may be administered at investigator's discretion if vitreous hemorrhage reduce or disappear after the intravitreal treatment with ranibizumab to such a retinal fundus visibility level that permits photocoagulation.

All the patients of the study will be monitored about adverse events and will remain in their usual clinical and ophthalmological care after the end of the study.

Visit Schedule

Day0 Day30 Day 60 Day 90 Informed Consent X Ophthalmologic Examination X X X X Best Corrected Visual Acuity X X X X Fluorescein Angiography X X X X Serum Glucose Level X X X X A/B Ultrasound Scan X* X* X* Ranibizumab Injection X X X Laser Treatment

• ** ** ** Adverse Events Monitoring X X X X

• Only for patients that present severe vitreous hemorrhages.

• At investigator's discretion. Check the Methodology section for details.

Population:

Patients with proliferative diabetic retinopathy with vitreous hemorrhage. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Hemorrhage
• Retinal Diseases
• Vitreous Hemorrhage

• NCT number: NCT01824043
• Study type: Interventional
• Source: Hospital Regional de São José - Dr. Homero de Miranda Gomes
• Contact: Dr Marcelo Novello, Chief
• Phone: 551832719094
• Email: mbnovell@yahoo.com
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2013
• Completion date: December 2013