A Study to Evaluate VV-14295 in Adults with GA Secondary to Age-related Macular Degeneration
Research type
Research Study
Full title
A Phase 1/2, First-in-Human, Multi-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of an Adeno-associated Virus Vector VV-14295 Administered Suprachoroidally with the Everads Injector In AdultS with GeographIc Atrophy Secondary to Age-related Macular Degeneration (the VISION Study)
IRAS ID
1011657
Contact name
Rizalyn Golnar
Contact email
Sponsor organisation
Kriya Therapeutics, Inc.
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD), a condition characterised by deterioration of the central area of the retina, ultimately resulting in blind spots and vision loss. GA affects over 5 million people globally and incidence increases drastically with age. Additionally, environmental and genetic factors including cigarette smoking, higher body mass index, hyperlipidemia, hypertension, familial history and some genetic components contribute to the risk of developing AMD and subsequent GA.
VV-14295 is a gene therapy being investigated for the treatment of GA. The goal of this study is to evaluate how safe and tolerable VV-14295 is and to determine how effective it is in reducing the growth of GA lesions in the treated eye. The study will also evaluate how well VV-14295 is administered using an investigational device called the Everads Injector, which is part of the investigational Everads Suprachoroidal Drug Delivery System.
The study is conducted in 3 parts:
1a: Dose escalation in patients with foveal GA lesions
1b: Safety assessment of the dose selected from Part 1a in patients with non-foveal lesions
Part 2: Safety and efficacy evaluation in patients with non-foveal lesions
Participants will receive a single dose of VV-14295 via suprachoroidal injection into one eye using the Everads Injector. In addition, oral corticosteroid and corticosteroid eye drops will be administered prior to and after VV-14295 dosing to reduce the risk of inflammation.
The maximum post treatment follow-up period is around 12 months. During this time participants will attend the study clinic for safety assessments and completion of a visual function questionnaire.
After completion of the study, participants will be asked to enroll in a long term follow-up study to collect additional safety and efficacy information for 4 years.
The study is funded and sponsored by Kriya Therapeutics, Inc.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0310
Date of REC Opinion
11 Dec 2025
REC opinion
Further Information Favourable Opinion