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

Part of paid clinical trials in Erie, Pennsylvania.

Sponsor
Kriya Therapeutics, Inc.
Study ID
NCT06765980
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Geographic Atrophy Secondary to Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Jan 9, 2025
Start date
May 28, 2025
Status verified
Sep 2025
Primary completion
Dec 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome 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 [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kriya Clinical Study SiteEriePennsylvania16505
VP, Medical Affairs
[email protected]
984-884-5058

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By research site
Kriya Clinical Study Site· Erie, PA

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