Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

Branch Retinal Vein Occlusion With Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03709745
• Other study ID #: 2017/2422-31
• Status: Recruiting
• Phase: Phase 4
• Start date: October 18, 2018
• Est. completion date: August 2022

Study information

• Verified date: December 2020
• Source: St. Erik Eye Hospital
• Contact: David Epstein, MD PhD
• Phone: +4686723000
• Email: david.epstein[@]sll.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion With Macular Edema
• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Aflibercept Injection [Eylea]
Intravitreal injection is given as described in the arm description
• Ranibizumab Injection [Lucentis]
Intravitreal injection is given as described in the arm description

Locations

Country	Name	City	State
Sweden	St Eriks Eye Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
St. Erik Eye Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Occurrence and evolution of macular ischemia over time	Area of non perfusion measured by OCT-angiography	9 moths
Secondary	Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs.		9 months
Secondary	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