Prospective Trial of Treat and Extend Aflibercept for Macular Edema Secondary to Branch Retinal V… (NCT03405376) | Clinical Trial Compass
UnknownPhase 4
Prospective Trial of Treat and Extend Aflibercept for Macular Edema Secondary to Branch Retinal Vein Occlusion
South Korea49 participantsStarted 2018-01-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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-naĂŻve 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 periocu…