Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

St. Erik Eye Hospital110 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

110

Conditions

Branch Retinal Vein Occlusion with Macular Edema

Interventions

Aflibercept Injection [Eylea]DRUG

Intravitreal injection is given as described in the arm description

Ranibizumab Injection [Lucentis]DRUG

Intravitreal injection is given as described in the arm description

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

St Eriks Eye Hospital

Stockholm, Stockholm County, Sweden

Outcomes

Primary Outcomes

Difference in time to recurrence of macular edema

Time, in weeks, from completion of loading dose to first recurrence of macular edema.

Time frame: 9 months

Secondary Outcomes

Comparison of the number of patients without ME in each treatment arm at one month after the first injection

The number of patients without macular edema at one month after the 1st injection in each treatment arm are compared

Time frame: 1 month

Comparison of the number of injections needed in each treatment arm to resolve ME

The number of injections needed for macular edema to resolve in each treatment arm are compared

Time frame: 9 months

Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs.

Time frame: 9 months

Data from ClinicalTrials.gov

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