Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

NCT03709745 | Completed Phase 4

• 1 other identifier: 2017/2422-31
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Branch Retinal Vein Occlusion with Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  1 month

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

  9 months

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

  9 months

Study Arms (2)

Aflibercept

ACTIVE COMPARATOR

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]

Ranibizumab

ACTIVE COMPARATOR

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]

Interventions

Aflibercept Injection [Eylea] DRUG

Intravitreal injection is given as described in the arm description

Also known as: Eylea

Aflibercept

Ranibizumab Injection [Lucentis] DRUG

Intravitreal injection is given as described in the arm description

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Erik Eye Hospital: lead

Study Sites (1)

St Eriks Eye Hospital

Stockholm, Stockholm County, 11282, Sweden

Location

MeSH Terms

Interventions

aflibercept; Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Anders Kvanta, MD PhD

  St. Erik Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 17, 2018
• Study Start: October 18, 2018
• Primary Completion: October 15, 2021
• Study Completion: July 10, 2022
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)