Navigated Laser In Branch Retinal Vein Occlusion Study

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.

Conditions

• Branch Retinal Vein Occlusion
• Macular Edema

Interventions

DRUG

Aflibercept Injection [Eylea]

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

PROCEDURE

Navigated laser photocoagulation

Navigated laser photocoagulation planned from flourscein angiography.

Sponsors & Collaborators

• Danske Regioner

  collaborator OTHER

• Synoptik-Fonden

  collaborator UNKNOWN

• Toyota-Fonden

  collaborator OTHER

• AP Moeller Foundation

  collaborator OTHER

• Yamagata University

  collaborator OTHER

• Queen's University, Belfast

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Region Sjællands og Region Syddanmarks forskningspulje

  collaborator UNKNOWN

• Odense University Hospital

  lead OTHER

Principal Investigators

• Katrine H Frederiksen, PhD-student · Research Unit of Ophthalmology, University of Southern Denmark

• Jakob Grauslund, DMSci,PhD · Research Unit of Ophthalmology, University of Southern Denmark

• Torben L Sørensen, DMSci · Dept. of Ophthalmology, Zealand University Hospital

• Jesper P Vestergaard, MD · Dept. of Ophthalmology, Odense University Hospital

• Inger C Munch, PhD · Dept. of Ophthalmology, Zealand University Hospital

• Tunde Peto, PhD · Queen's University, Belfast, England

• Ryo Kawasaki, PhD · Yamagata, University, Japan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-10

Primary Completion

2021-10-05

Completion

2021-10-05

Countries

• Denmark

Study Locations