Navigated Laser In Branch Retinal Vein Occlusion Study
Status:
Active, not recruiting
Trial end date:
2021-08-10
Target enrollment:
Participant gender:
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
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