A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration (VISION)

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration
• Intervention / Treatment: Genetic: VV-14295

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: VP, Medical Affairs; Phone Number: 984-884-5058; Email: clinicaltrials@kriyatx.com

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Recruiting
      • Kriya Clinical Study Site
      • Contact: VP, Medical Affairs; Phone Number: 984-884-5058; Email: clinicaltrials@kriyatx.com
• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Kriya Clinical Study Site
    • Contact: VP, Medical Affairs; Phone Number: 984-884-5058; Email: clinicaltrials@kriyatx.com
• New Zealand
  • Christchurch, New Zealand
    • Recruiting
    • Kriya Clinical Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1a, low dose; A single low dose of VV-14295 will be administered on Day 1. In addition, oral prednisone and difluprednate eye drops will be administered prior to and after VV-14295 dosing to reduce the risk of inflammation. After several weeks, participants will switch from difluprednate to prednisolone acetate eye drops.	Genetic: VV-14295; VV-14295 will be administered as a single suprachoroidal injection.
Experimental: Part 1a, high dose; A single high dose of VV-14295 will be administered on Day 1. In addition, oral prednisone and difluprednate eye drops will be administered prior to and after VV-14295 dosing to reduce the risk of inflammation. After several weeks, participants will switch from difluprednate to prednisolone acetate eye drops.	Genetic: VV-14295; VV-14295 will be administered as a single suprachoroidal injection.
Experimental: Part 1b; A single dose of VV-14295 determined from Part 1a will be administered on Day 1. In addition, oral prednisone and difluprednate eye drops will be administered prior to and after VV-14295 dosing to reduce the risk of inflammation. After several weeks, participants will switch from difluprednate to prednisolone acetate eye drops.	Genetic: VV-14295; VV-14295 will be administered as a single suprachoroidal injection.
Experimental: Part 2; A single dose of VV-14295 determined from Part 1a will be administered on Day 1. In addition, oral prednisone and difluprednate eye drops will be administered prior to and after VV-14295 dosing to reduce the risk of inflammation. After several weeks, participants will switch from difluprednate to prednisolone acetate eye drops.	Genetic: VV-14295; VV-14295 will be administered as a single suprachoroidal injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Evaluate Part 1 safety of VV-14295 in foveal and non-foveal patients	12 months
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	Evaluate Part 2 safety of VV-14295 in non-foveal GA patients	12 months
Rate of GA progression as assessed by optical coherence tomography (OCT)	Part 2 efficacy of VV-14295	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of GA progression as assessed by fundus autofluorescence (FAF)	Parts 1 and 2 efficacy of VV-14295	3, 6, and 12 months
Rate of GA progression as assessed by OCT	Parts 1 and 2 efficacy of VV-14295	3, 6, and 12 months
Visual function preservation as assessed by best-corrected visual acuity (BCVA)	Parts 1 and 2 efficacy of VV-14295	3, 6, and 12 months
Visual function preservation as assessed by low luminance visual acuity (LLVA)	Parts 1 and 2 efficacy of VV-14295	3, 6, and 12 months
Visual function preservation as assessed by microperimetry	Parts 1 and 2 efficacy of VV-14295	3, 6, and 12 months
VV-14295 transgene product expression	Concentrations of AAV vector-mediated transgene product in serum	12 months
Immune response to VV-14295	Humoral and cellular responses to AAV2 capsid and transgene product; anti-AAV2 neutralization capacity in serum	12 months
Vector shedding profile of VV-14295	Vector shedding in serum, tears, mucus, and urine	12 months
Safety of Everads Injector	Frequency of device-related adverse events and serious adverse events	1 day post-dose

Collaborators and Investigators

• Sponsor: Kriya Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Pathological Conditions, Anatomical; Eye Diseases; Neoplastic Processes; Retinal Diseases; Retinal Degeneration; Neoplasm Metastasis; Atrophy; Macular Degeneration; Geographic Atrophy
• Other Study ID Numbers: KRIYA-825-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes