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OpenTrials
Completed

NCT Number: NCT03709745

Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Eriks Eye Hospital

Stockholm, Stockholm County, 11282, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aflibercept Injection [Eylea]

Drug

Intravitreal injection is given as described in the arm description

Other names: Eylea

Ranibizumab Injection [Lucentis]

Drug

Intravitreal injection is given as described in the arm description

Other names: Lucentis

Primary outcomes

  1. Difference in time to recurrence of macular edema

    Time frame: 9 months

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

Secondary outcomes

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

    Time frame: 1 month

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

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

    Time frame: 9 months

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

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

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

St. Erik Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Oct 17, 2018
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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