Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

Last updated: October 24, 2024
Sponsor: St. Erik Eye Hospital
Overall Status: Completed

Phase

4

Condition

Macular Edema

Treatment

Aflibercept Injection [Eylea]

Ranibizumab Injection [Lucentis]

Clinical Study ID

NCT03709745
2017/2422-31
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Aflibercept Injection [Eylea]
Phase: 4
Study Start date:
October 18, 2018
Estimated Completion Date:
July 10, 2022

Study 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.

Connect with a study center

  • St Eriks Eye Hospital

    Stockholm, 11282
    Sweden

    Site Not Available

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