FDA approves expansion of NeoVista's Phase III CABERNET trial

Article

The FDA has approved an expansion of the Phase III CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy) trial, which is evaluating the safety and efficacy of NeoVista's epiretinal brachytherapy in wet age-related macular degeneration (AMD).

The FDA has approved an expansion of the Phase III CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy) trial, which is evaluating the safety and efficacy of NeoVista's epiretinal brachytherapy in wet age-related macular degeneration (AMD). There will now be 30 sites worldwide participating in the study, as opposed to the previously authorized 10, enrolling 450 subjects.

CABERNET, a multicentre, randomized, controlled study, will evaluate the safety and efficacy of NeoVista's epiretinal brachytherapy with Lucentis (ranibizumab; Novartis) versus Lucentis alone. Subjects in the brachytherapy study arm will receive an intravitreal injection of Lucentis and a single dose (24 Gy) of the epiretinal brachytherapy; these subjects will receive a second intravitreal Lucentis injection approximately one month later.

The trial aims to prove either the non-inferiority or the superiority of epiretinal brachytherapy plus Lucentis versus Lucentis alone at 12 months from baseline. Visual acuity (VA) of study subjects will be measured on the ETDRS scale.

NeoVista's Phase II trial, evaluating brachytherapy in combination with Avastin (bevacizumab), demonstrated an improvement in mean VA in subjects using brachytherapy plus Avastin; adverse events in the Phase II trial were limited to vitrectomy-related problems and not to radiation toxicity. The approved expansion of CABERNET was dependent on the FDA's review of 90-day safety data.

Recent Videos
Anat Loewenstein, MD, speaks about the 22nd Annual Angiogenesis, Exudation, and Degeneration Meeting in February 2025 and shares her global forecast for AI-driven home OCT
Sarah M. Thomasy, DVM, PhD, DACVO, a veterinary ophthalmologist at UC Davis, talks about how her research at the Glaucoma 360 symposium
I. Paul Singh, MD, an anterior segment and glaucoma specialist, discusses the Glaucoma 360 conference, where he participated in a panel discussion on the use of artificial intelligence (AI) in glaucoma care.
Charles Wykoff, MD, PhD, discusses his Floretina ICOOR presentation topic, retinal non-perfusion in diabetic retinopathy, with David Hutton, editor of Ophthalmology Times
Elizabeth Cohen, MD, discusses the Zoster Eye Disease study at the 2024 AAO meeting
Victoria L Tseng, MD, PhD, professor of ophthalmology and glaucoma specialist, UCLA
Brent Kramer, MD, of Vance Thompson Vision speaks at the 2024 AAO meeting
Related Content
© 2025 MJH Life Sciences

All rights reserved.