Clinical trial NCT06765980: A Study to Evaluate KRIYA-825 (VV-14295) in Adults with Geographic Atrophy Secondary to Age-related Macular Degeneration
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration
Lead sponsor: Kriya Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-09
Enrollment: 62
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Rate of GA progression as assessed by optical coherence tomography (OCT)
timeFrame: 12 months
Secondary outcomes:
measure: Rate of GA progression as assessed by fundus autofluorescence (FAF)
timeFrame: 3, 6, and 12 months
measure: Rate of GA progression as assessed by OCT
timeFrame: 3, 6, and 12 months
measure: Visual function preservation as assessed by best-corrected visual acuity (BCVA)
timeFrame: 3, 6, and 12 months
measure: Visual function preservation as assessed by low luminance visual acuity (LLVA)
timeFrame: 3, 6, and 12 months
measure: Visual function preservation as assessed by microperimetry
timeFrame: 3, 6, and 12 months
measure: VV-14295 transgene product expression
timeFrame: 12 months
measure: Immune response to VV-14295
timeFrame: 12 months
measure: Vector shedding profile of VV-14295
timeFrame: 12 months
measure: Safety of Everads Injector
timeFrame: 1 day post-dose
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Kriya Clinical Study Site
Study officials:
References: