OBSERVE Study
Research type
Research Study
Full title
A Multicenter, OBSERVational Study in PatiEnts with Geographic Atrophy Secondary to Age-related Macular Degeneration (OBSERVE)
IRAS ID
356315
Contact name
Nicholas Beare
Contact email
Sponsor organisation
Kriya Therapeutics, Inc
Clinicaltrials.gov Identifier
ACTRN12625000877482
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
KRIYA-825-901(OBSERVE) is an observational study of participants with Geographic Atrophy (GA), which is an advance form of age-related macular degeneration.
This is a 2-part study run in parallel to the First in Human KRIYA-825-101(VISION) open label study, designed to test how safe, tolerable and effective a gene therapy (VV-14295) is at treating GA.
In part 1 of this study investigators review potential participants’ medical charts and retrospective eye examination records since 2022 to determine if they are eligible for the KRIYA-825-101 study.
If participants are found not to be eligible for the VISION study, they will be enrolled onto Part 2 of the OBSERVE study.
Part 2 will provide a matched control group for the VISION study. Data will be collected to compare disease progression between participants treated with gene therapy, VV-14295.
Overall creating, real world data on disease progression, essential for the understanding of safety, efficacy and comparative effectiveness of gene therapies, with a view of improving future treatments for patients with GA.
This study is sponsored by Kriya Therapeutics, Inc.
Approximately 120 participants will be enrolled in Part 1 and 60 in Part 2 globally,REC name
East of Scotland Research Ethics Service REC 1
REC reference
25/ES/0056
Date of REC Opinion
1 Jul 2025
REC opinion
Favourable Opinion