Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion
- Sponsor
- St. Erik Eye Hospital
- Study ID
- NCT03709745
- Phase
- PHASE4
- Status
- Completed
Conditions
- Branch Retinal Vein Occlusion with Macular Edema
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Aflibercept Injection [Eylea] — DRUGIntravitreal injection is given as described in the arm description
- Ranibizumab Injection [Lucentis] — DRUGIntravitreal injection is given as described in the arm description
Study Details
Comparing time to recurrence of macular edema after an initial loading dose of at least three monthly anti VEGF injections (aflibercept or ranibizumab) for macular edema in BRVO.
Key Dates
- Start date
- Oct 18, 2018
- Status verified
- Oct 2024
- Primary completion
- Oct 15, 2021
- Completion
- Jul 10, 2022
Study Design
- Enrollment
- 110 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: AfliberceptAflibercept is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given aflibercept according to a treat-and-extend regimen.
- Active Comparator: RanibizumabRanibizumab is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given ranibizumab according to a treat-and-extend regimen.
Primary Outcome Measure
Difference in time to recurrence of macular edema [ Time Frame: 9 months ]