Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

Phase 4

Completed

• Conditions: Branch Retinal Vein Occlusion with Macular Edema
• Interventions: Drug: Ranibizumab Injection [Lucentis]; Drug: Aflibercept Injection [Eylea]

• Registration Number: NCT03709745
• Lead Sponsor: St. Erik Eye Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Study Start: 2018-10-18
• Primary Completion: 2021-10-15
• Study Completion: 2022-07-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• BRVO naïve patients, disease duration 1-6 months, BCVA 23-73 ETDRS letters (20/40-20/320), macula edema with intraretinal cysts and CRT > 300 micrometers (Cirrus)

Exclusion Criteria

• BRVO with neovascular component, intraocular surgery during the previous 3 months, earlier vitreoretinal surgery, vascular retinopathy of other cause, intraocular infection/inflammation, myocardial infarction och cerebrovascular stroke during the last 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Ranibizumab Injection [Lucentis]	Ranibizumab 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.
Aflibercept	Aflibercept Injection [Eylea]	Aflibercept 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.

Primary Outcome Measures

Name	Time	Method
Difference in time to recurrence of macular edema	9 months	Time, in weeks, from completion of loading dose to first recurrence of macular edema.

Secondary Outcome Measures

Name	Time	Method
Comparison of the number of patients without ME in each treatment arm at one month after the first injection	1 month	The number of patients without macular edema at one month after the 1st injection in each treatment arm are compared
Comparison of the number of injections needed in each treatment arm to resolve ME	9 months	The number of injections needed for macular edema to resolve in each treatment arm are compared
Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs.	9 months

Trial Locations

Locations (1)

St Eriks Eye Hospital; 🇸🇪 Stockholm, Sweden