Navigated Laser In Branch Retinal Vein Occlusion Study

• Status: Active, not recruiting
• Trial end date: 2021-08-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital
• Collaborators: AP Moeller Foundation; Danske Regioner; Queen's University, Belfast; Region Sjællands og Region Syddanmarks forskningspulje; Synoptik-Fonden; Toyota-Fonden; Yamagata University; Zealand University Hospital
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• Patients with BRVO with foveal center-involved macular edema in the study eye.

• Best-corrected visual acuity (BCVA) 35-80 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (0.1-0.8 Snellen equivalent) in the study eye at baseline (BL).

• Age ≥18 years.

• Central retinal thickness > 300 μm in the study eye at BL.

• Onset ≤ 6 months prior to the study.

Exclusion Criteria:

• Active retinal or iris neovascularizations in the study eye at any time.

• Cataract, vitreous hemorrhage or other clouding conditions that prevent retinal laser photocoagulation in the study eye at M3.

• Prior anti-VEGF treatment or macular laser photocoagulation in the study eye.

• Macular edema and/or increased retinal thickness due to other potential causes than BRVO

• Uncontrolled hypertension (blood pressure ≥ 160/110 mmHg).