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

NCT06765980 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: KRIYA-825-101
• Study Type: interventional
• Target: 62
• Locations: 3 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Rate of GA progression as assessed by fundus autofluorescence (FAF)

  3, 6, and 12 months

• Rate of GA progression as assessed by OCT

  3, 6, and 12 months

• Visual function preservation as assessed by best-corrected visual acuity (BCVA)

  3, 6, and 12 months

• Visual function preservation as assessed by low luminance visual acuity (LLVA)

  3, 6, and 12 months

• Visual function preservation as assessed by microperimetry

  3, 6, and 12 months

Study Arms (4)

Part 1a, low dose

EXPERIMENTAL

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

Part 1a, high dose

EXPERIMENTAL

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

Part 1b

EXPERIMENTAL

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

Part 2

EXPERIMENTAL

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

Interventions

VV-14295 GENETIC

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

Part 1a, high dose; Part 1a, low dose; Part 1b; Part 2

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Prior participation in another interventional clinical study for GA within the past 12 months from the last dosing at Screening.

Sponsors & Collaborators

• Kriya Therapeutics, Inc.: lead

Study Sites (3)

Kriya Clinical Study Site

Ottawa, Ontario, Canada

RECRUITING

Kriya Clinical Study Site

Tel Aviv, Israel

RECRUITING

Kriya Clinical Study Site

Christchurch, New Zealand

RECRUITING

Central Study Contacts

VP, Medical Affairs

CONTACT

984-884-5058; clinicaltrials@kriyatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 9, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: April 30, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); NZ (1); CA (1)