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: Unknown
• 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 (Anticipated): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11282
    • Recruiting
    • St Eriks Eye Hospital
    • Contact: David Epstein, M.D; Phone Number: +46 86723228; Email: david.epstein@sankterik.se
    • Contact: Anders Kvanta, M.D PhD; Phone Number: +46 86720000; Email: anders.kvanta@sankterik.se
    • Principal Investigator: David Epstein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• 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
Occurrence and evolution of macular ischemia over time	Area of non perfusion measured by OCT-angiography	9 moths
Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs.		9 months
Correlation of vision related QoL in patients with a good visual acuity and findings on visual fields, retinal sensitivity, macular ischemia and near VA.		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 (ANTICIPATED): November 1, 2021
• Study Completion (ANTICIPATED): August 1, 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): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

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

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