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Clinical Trial Summary

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.


Clinical Trial Description

One hundred and ten patients with macular edema (ME) secondary to BRVO are randomized (1:1) to treatment with intravitreal injections of aflibercept or ranibizumab. An initial loading dose of at least three monthly injections is given in the study eye until the ME is resolved. Then patients are observed at regular intervals, initially every four weeks until study completion. Total follow-up time is nine months from baseline to completion. If ME recurs, patients are treated according to a treat-and-extend algorithm. At every visit, visual acuity (VA) is measured with an ETDRS chart at 4 m. The fundus is examined by indirect ophthalmoscopy and by optical coherence tomography (OCT). Macular ischemia is evaluated with OCT angiography (OCT-A), visual field status with computerised perimetry and retinal sensitivity with microperimetry. Choroidal thickness is evaluated with enhanced depth imaging (EDI) OCT. Vision related quality of life (QoL) with NEI VFQ25. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03709745
Study type Interventional
Source St. Erik Eye Hospital
Contact David Epstein, MD PhD
Phone +4686723000
Email david.epstein@sll.se
Status Recruiting
Phase Phase 4
Start date October 18, 2018
Completion date August 2022

See also
  Status Clinical Trial Phase
Completed NCT02556723 - Intravitreal Injections of Ziv-aflibercept for Macular Diseases N/A
Completed NCT02006147 - Phase 1 Open-label Study to Evaluate Efficacy and Tolerability of TLC399 in Patients With Macular Edema Due to RVO Phase 1/Phase 2
Recruiting NCT03892434 - Bevacizumab Versus DEX Implant Followed by Bevacizumab in ME Secondary to BRVO Phase 4
Recruiting NCT03405376 - Prospective Trial of Treat and Extend Aflibercept for Macular Edema Secondary to Branch Retinal Vein Occlusion Phase 4