Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-18

Study Completion Date

2022-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema

NCT04018833

Diabetic Macular Edema Diabetic Retinopathy

COMPLETED

Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema

NCT02646670

Retinal Diseases

COMPLETED PHASE4

Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions

NCT00407355

Macular Edema Retinal Vein Occlusion

COMPLETED PHASE1/PHASE2

Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO

NCT02091505

Central Retinal Vein Occlusion

UNKNOWN NA

Ranibizumab Versus Aflibercept for CRVO in Young Patients.

NCT05282420

Non-Ischemic Central Retinal Vein Occlusion With Macular Edema

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Branch Retinal Vein Occlusion with Macular Edema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aflibercept

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.

Group Type ACTIVE_COMPARATOR

Aflibercept Injection [Eylea]

Intervention Type DRUG

Intravitreal injection is given as described in the arm description

Ranibizumab

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.

Group Type ACTIVE_COMPARATOR

Ranibizumab Injection [Lucentis]

Intervention Type DRUG

Intravitreal injection is given as described in the arm description

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aflibercept Injection [Eylea]

Intravitreal injection is given as described in the arm description

Intervention Type DRUG

Ranibizumab Injection [Lucentis]

Intravitreal injection is given as described in the arm description

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Eylea Lucentis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No