VISIONVV-14295 for Geographic Atrophy in Age-related Macular Degeneration
VV-14295
Treatment Study
Summary
Study start date: May 28, 2025
Actual date on which the first participant was enrolled.This study aims to assess the safety and effectiveness of a new treatment called KRIYA-825 (VV-14295) for individuals with a specific eye condition known as geographic atrophy (GA) caused by age-related macular degeneration (AMD). Geographic atrophy is a serious condition leading to vision loss in older adults, and there is a significant need for treatments that can slow down or stop its progression. By testing this treatment, the study hopes to find a potential way to reduce the growth of GA lesions, which are damaged areas in the eye that worsen over time. Participants in the study will receive the KRIYA-825 treatment through a method called suprachoroidal injection, using a special device called the Everads Injector. This way of delivering the treatment targets the affected areas in the eye more directly. The study will focus on observing the safety and tolerability of the treatment, which means checking for any side effects or discomforts, and evaluating its effectiveness in slowing down the growth of GA lesions. While the study does not list specific outcomes, it is an important step in finding a treatment for those suffering from this vision-threatening condition.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.62 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 55 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * Participant must be between 55 to 80 years of age (inclusive), at the time of signing the informed consent form. * Body mass index (BMI) of 19 to 34 kg/m2 (inclusive). * Must agree to use reliable contraception for at least 12 months after administration of VV-14295. A female participant is eligible to participate if she is not pregnant and not breastfeeding. * The GA lesion must meet certain criteria as assessed by a central reading center's assessment of imaging at Screening. * Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator. * For study eye, Normal Luminance BCVA of 55 letters or worse using the ETDRS charts (20/80 or worse) for Part 1a participants or 24 letters or better (approximately 20/320 Snellen equivalent) for Part 1b and Part 2 participants. * Fellow eye Normal Luminance BCVA of 5 letters or better using ETDRS charts (20/800 or better) for Part 1a participants or 24 letters or better (approximately 20/320 Snellen equivalent or better) for Part 1b and Part 2 participants. Fellow eye must have equivalent or better visual acuity than the study eye. Exclusion Criteria: * Any ocular disease or condition that is not GA secondary to AMD: Macular atrophy secondary to a condition other than AMD; Exudative AMD diagnosis or any history of or active macular neovascularization (in study eye or fellow eye) and/or retinal angiomatous proliferation associated with AMD or any other cause; Presence of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function; Active ocular or periocular infection or active uncontrolled intraocular inflammation within 3 months of Screening; History of vitrectomy, retinal detachment, or corneal transplant in the study eye; Active/history of uveitis. * Any ocular condition that prevents adequate imaging. * Medical, cognitive or psychiatric conditions that, in the opinion of the Investigator, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or could increase the risk to the participant by participating in the study or confound the outcome of the study. * Hospitalization within 1 year prior to Screening that, in the opinion of the Investigator, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or could increase the risk to the participant by participating in the study or confound the outcome of the study. * Any Screening test (e.g., ECG) or laboratory value (e.g., hematology) that in the opinion of the Investigator and/or Medical Monitor is clinically significant and renders the participant not suitable for study participation. * Participant has a direct contraindication to the steroid regimen (both oral and topical) or has a condition that significantly increases the risk of complication. * Active/history of malignancy within the past 5 years from Screening or any previous therapeutic radiation in the region of the study eye(s) at Screening. History of non-melanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia (CIN), and localized prostate cancer after treatment are not exclusionary. * Intraocular surgery (including lens replacement surgery) within 3 months prior to Screening. * History of laser therapy in the macular region. * History of intravitreal (IVT) therapy, such as IVT steroid injections, within 6 months prior to Screening. * COVID-19 vaccine within 90 days of Screening or plan to receive COVID-19 vaccine within 6 months of treatment. * Active use of systemic immunomodulatory drugs or systemic corticosteroids in the last 60 days. Topical steroids are not exclusionary. * Prior participation in another interventional clinical study for GA within the past 12 months from the last dosing at Screening.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Kriya Clinical Study Site
Christchurch, New Zealand