Overview

Prospective Trial of Treat and Extend Aflibercept for Macular Edema Secondary to Branch Retinal Vein Occlusion

Status:
Unknown status
Trial end date:
2020-09-30
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of the treat-and-extend regimen extending to 4 months by intervals of 4 weeks using intravitreal aflivercept injection for treatment of macular edema secondary to BRVO.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yeungnam University College of Medicine
Treatments:
Aflibercept
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).

- Adult subjects diagnosed with macular edema secondary to BRVO who are scheduled to be
treated with intravitreal aflibercept as per investigator's routine treatment practice
with the intent to use a T&E regimen after initial treatment.

- Treatment-naïve subjects for macular edema secondary to BRVO.

- Both ischemic and non-ischemic BRVO, which are confirmed by FA at baselin, week 24 and
week 72.

- Men and women ≥ 18 years of age.

- Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40
to 20/320) in the study eye.

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.