Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

A Randomized Trial Comparing Treatment with Aflibercept and Ranibizuamab for Macular Edema After 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.

Study Overview

• Status: Completed
• Conditions: Branch Retinal Vein Occlusion with Macular Edema
• Intervention / Treatment: Drug: Aflibercept Injection [Eylea]; Drug: Ranibizumab Injection [Lucentis]

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11282
    • St Eriks Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Aflibercept Injection [Eylea]; Intravitreal injection is given as described in the arm description; Other Names: Eylea
Active Comparator: 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.	Drug: Ranibizumab Injection [Lucentis]; Intravitreal injection is given as described in the arm description; Other Names: Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in time to recurrence of macular edema	Time, in weeks, from completion of loading dose to first recurrence of macular edema.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	9 months
Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs.		9 months

Collaborators and Investigators

• Sponsor: St. Erik Eye Hospital
• Investigators: Principal Investigator: Anders Kvanta, MD PhD, St. Erik Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): July 10, 2022

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Embolism and Thrombosis; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Venous Thrombosis; Thrombosis; Edema; Macular Edema; Retinal Vein Occlusion; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab; Aflibercept
• Other Study ID Numbers: 2017/2422-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No