Bevacizumab Versus DEX Implant Followed by Bevacizumab in ME Secondary to BRVO

• Status: Unknown status
• Trial end date: 2020-06-18
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of sequential therapy with intravitreal dexamethasone implant followed by bevacizumab compared with bevacizumab monotherapy for macular edema (ME) secondary to retinal vein occlusion (RVO).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yeungnam University College of Medicine
• Treatments: BB 1101; Bevacizumab; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

Center-involved macular edema secondary to BRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit).

Exclusion Criteria:

• Previous PRP or macular laser photocoagulation in the study eye.

• Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to BRVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded.

• Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study.

• Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1.

• Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening.

• Any history of allergy to povidone iodine.

• Known serious allergy to the fluorescein sodium for injection in angiography.

• Presence of any contraindications indicated in the EU commission/locally approved label for intravitreal aflibercept: hypersensitivity to the active substance intravitreal aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.