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Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage

NCT01824043 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-04-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

intravitreal ranibizumab injections

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

Sponsors & Collaborators

  • Hospital Regional de São José - Dr. Homero de Miranda Gomes

    lead OTHER

Principal Investigators

  • Marcelo Novello · Hospital Regional Sao Jose

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-09-30
Completion
2013-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01824043 on ClinicalTrials.gov