Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage

Sponsor
Hospital Regional de São José - Dr. Homero de Miranda Gomes
Study ID
NCT01824043
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • intravitreal ranibizumab injections — DRUG
    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

Study Details

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.

Key Dates

First listed
Apr 4, 2013
Start date
Mar 31, 2013
Status verified
Apr 2013
Primary completion
Sep 30, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: vitreous hemorrhage group
    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

Primary Outcome Measure

Gain in visual acuity and transparence of vitreous in treated eyes. [ Time Frame: 90 days ]

Central Contacts

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