BRVO.

• Conditions: macular edema secondary to a retinal vein occlusion

• Registration Number: NL-OMON23545
• Lead Sponsor: Academic Medical Center (AMC)Department of Ophthalmology

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 296

Inclusion Criteria

1. Male or female patients > 18 years of age with vision loss due to foveal center-involved ME secondary to branch or central retinal vein occlusion diagnosed within 6 months before study initiation, who have signed an informed consent;

2. BCVA equal or more than 24 and less or equal to 78 letters in the study eye at screening using ETDRS- like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320);

Exclusion Criteria

1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent;

2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum pregnancy test (human chorionic gonadotropin > 5 mIU/ml);

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the change in best-corrected visual acuitiy (BCVA) in the study eye from baseline to month 6 assessed with EDTRS-like VA charts at an initial distance of four meter.

Secondary Outcome Measures

Name	Time	Method
1. The proportion of patients with a loss of BCVA less than 15 letters from baseline at 6 months (responders);<br /><br>2. The proportion of patients with a loss or gain of BCVA less than 15 letters from baseline at 6 months (stabilizers);<br /><br>3. The proportion of patients with 15 letters loss or more of BCVA from baseline at 6 months (non-responders);<br /><br>4. The proportion of patients with 15 letters gain or more of BCVA from baseline at 6 months (gainers);<br /><br>5. The incidence of fluorescein leakage at 6 months as well as the change from baseline at 6 months as determined by the reading centre;<br /><br>6. Absolute and percent change in retinal thickness, as measured by optical coherence tomography (OCT) at 6 months as determined by the reading centre;<br /><br>7. Proportion of dropouts before the final 6 months assessment;<br /><br>8. The occurrence of (serious) adverse events during the 6 months of the study;<br /><br>9. Costs of the two treatments.