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

NCT ID: NCT06765980

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2027-12-15

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).

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

VV-14295

Intervention Type: GENETIC

VV-14295 will be administered as a single suprachoroidal injection.

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.

Group Type: EXPERIMENTAL

VV-14295

Intervention Type: GENETIC

VV-14295 will be administered as a single suprachoroidal injection.

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.

Group Type: EXPERIMENTAL

VV-14295

Intervention Type: GENETIC

VV-14295 will be administered as a single suprachoroidal injection.

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.

Group Type: EXPERIMENTAL

VV-14295

Intervention Type: GENETIC

VV-14295 will be administered as a single suprachoroidal injection.

Interventions

VV-14295

VV-14295 will be administered as a single suprachoroidal injection.

Intervention Type: GENETIC

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kriya Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kriya Clinical Study Site

Ottawa, Ontario, Canada

Site Status: RECRUITING

Kriya Clinical Study Site

Christchurch, , New Zealand

Site Status: RECRUITING

Countries

Canada; New Zealand

Central Contacts

VP, Medical Affairs

Role: CONTACT

clinicaltrials@kriyatx.com

984-884-5058

Facility Contacts

VP, Medical Affairs

Role: primary

clinicaltrials@kriyatx.com

984-884-5058

Other Identifiers

KRIYA-825-101

Identifier Type: -

Identifier Source: org_study_id