NCT03709745

Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

A Randomized Trial Comparing Treatment with Aflibercept and Ranibizuamab for Macular Edema After Branch Retinal Vein Occlusion

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: St. Erik Eye Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Branch Retinal Vein Occlusion with Macular Edema

Interventions

Type	Name	Description
DRUG	Aflibercept Injection [Eylea]	Intravitreal injection is given as described in the arm description
DRUG	Ranibizumab Injection [Lucentis]	Intravitreal injection is given as described in the arm description

Timeline

• Start date: 2018-10-18
• Primary completion: 2021-10-15
• Completion: 2022-07-10
• First posted: 2018-10-17
• Last updated: 2024-10-28

Locations

1 site across 1 country: Sweden