Diabetic Retinopathy Clinical Trial
Official title:
Pilot Study Investigating the Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage in Proliferative Diabetic Retinopathy
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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