CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
Aflibercept Injection [Eylea] +1 moredrug
Likely dose
Aflibercept Injection [Eylea] 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03651011
NCT03651011N/ACompleted

Navigated Laser In Branch Retinal Vein Occlusion Study

Odense University Hospital·interventional·Posted Aug 29, 2018·Updated Apr 20, 2022

In Brief

A clinical study evaluating Aflibercept Injection [Eylea] and Navigated laser photocoagulation for Branch Retinal Vein Occlusion and Macular Edema. Completed, enrolled 47 participants across 2 sites.

Detailed Summary

Branch retinal vein occlusion (BRVO) is often complicated by macular edema, possibly leading to severe visual loss or blindness. Treatment is repeated, intravitreal injections of vascular endothelial growth factor (VEGF)-inhibitors like aflibercept. The treatment is effective, but a need for repetitive injections is a concern for patients as well as society due to risk of side effects, regular hospital visits and the price of the drug. Former treatment included macular grid pattern photocoagulation, but this technology was limited by a poorer visual outcome for the patient and a higher risk of side effects, including central visual loss. A novel laser delivery system, called navigated laser photocoagulation, has proven effective, safe and precise, and has shown promising results in stabilising the effect of the VEGF-inhibitor treatment in similar diseases. Thus, in a 12-month prospective, randomized 1:1 study of 60 patients with BRVO and macular edema the investigators aim to (1) Examine the treatment response of patients treated with intravitreal aflibercept (Eylea®) and navigated retinal laser (Navilas®)(Group 1) as compared to patients treated with intravitreal aflibercept only (Group 2), and (2) Identify non-invasive retinal biomarkers (retinal oxygen saturation, macular ischemia and retinal vascular arteriolar and venular calibre) for successful treatment outcome.

Study Details

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 29, 2018
Enrollment StartAug 10, 2018
Primary CompletionOct 5, 2021
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.8 years ago

Interventions

Aflibercept Injection [Eylea]drug

Intravitreal injection 2 mg Eylea every 4 weeks M0-M2 (loading phase). M3-M12: continue in a pro re nata treatment regimen.

Navigated laser photocoagulationprocedure

Navigated laser photocoagulation planned from flourscein angiography.