Geographic Atrophy Secondary to Age-related Macular Degeneration
Conditions
Brief summary
The goal of this study is to evaluate how safe and tolerable KRIYA-825 (VV-14295) is and to determine how effective it is in reducing the growth of geographic atrophy (GA) lesions in the treated eye in patients with GA secondary to age-related macular degeneration (AMD).
Interventions
GENETICVV-14295
VV-14295 will be administered as a single suprachoroidal injection.
Sponsors
Kriya Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of ocular and non-ocular adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and abnormal ophthalmic findings | 12 months | Evaluate Part 1 safety of VV-14295 in foveal and non-foveal patients |
| Incidence and severity of ocular and non-ocular adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal ECGs, and abnormal ophthalmic findings | 12 months | Evaluate Part 2 safety of VV-14295 in non-foveal GA patients |
| Rate of GA progression as assessed by optical coherence tomography (OCT) | 12 months | Part 2 efficacy of VV-14295 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of GA progression as assessed by fundus autofluorescence (FAF) | 3, 6, and 12 months | Parts 1 and 2 efficacy of VV-14295 |
| Rate of GA progression as assessed by OCT | 3, 6, and 12 months | Parts 1 and 2 efficacy of VV-14295 |
| Visual function preservation as assessed by best-corrected visual acuity (BCVA) | 3, 6, and 12 months | Parts 1 and 2 efficacy of VV-14295 |
| Visual function preservation as assessed by low luminance visual acuity (LLVA) | 3, 6, and 12 months | Parts 1 and 2 efficacy of VV-14295 |
| Visual function preservation as assessed by microperimetry | 3, 6, and 12 months | Parts 1 and 2 efficacy of VV-14295 |
| VV-14295 transgene product expression | 12 months | Concentrations of AAV vector-mediated transgene product in serum |
| Immune response to VV-14295 | 12 months | Humoral and cellular responses to AAV2 capsid and transgene product; anti-AAV2 neutralization capacity in serum |
| Vector shedding profile of VV-14295 | 12 months | Vector shedding in serum, tears, mucus, and urine |
| Safety of Everads Injector | 1 day post-dose | Frequency of device-related adverse events and serious adverse events |
Countries
Canada, Israel, New Zealand, United States
Contacts
CONTACTVP, Medical Affairs
Outcome results
None listed