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A Phase 1/2, First-in-Human, Multi-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of VV-14295 Administered Suprachoroidally With the Everads Injector in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration
Led by Kriya Therapeutics, Inc. · Updated on 2026-04-30
62
Participants Needed
3
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of KRIYA-825 (VV-14295) in adults with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This study aims to determine how well VV-14295 reduces the growth of GA lesions in the treated eye. Participants receive a single suprachoroidal injection of VV-14295 on Day 1. To reduce inflammation, oral prednisone and difluprednate eye drops are given before and after the injection, with a later switch from difluprednate to prednisolone acetate eye drops. The study includes multiple parts with different dosing levels, including low dose, high dose, and doses determined from earlier parts of the study. Throughout the 12-month study period, participants undergo various eye imaging tests such as optical coherence tomography (OCT) and fundus autofluorescence (FAF) to monitor GA progression. Visual function is assessed by tests including best-corrected visual acuity (BCVA), low luminance visual acuity (LLVA), and microperimetry. Safety is closely monitored through eye exams, physical assessments, lab tests, and recording any side effects or abnormal findings. The study also evaluates immune response and vector shedding related to VV-14295.
CONDITIONS
Brief Title
A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Female participants must not be pregnant or breastfeeding.
- The geographic atrophy lesion must meet criteria as assessed by central imaging at screening.
- Adequate clarity of ocular media, pupillary dilation, and fixation to allow good quality image collection.
- For the study eye, Normal Luminance BCVA of 55 letters or worse (20/80 or worse) for Part 1a participants or 24 letters or better (approximately 20/320) for Part 1b and Part 2 participants.
- For the fellow eye, Normal Luminance BCVA of 5 letters or better (20/800 or better) for Part 1a participants or 24 letters or better (approximately 20/320) for Part 1b and Part 2 participants.
- Fellow eye must have equivalent or better visual acuity than the study eye.
You will not qualify if you...
- Any ocular disease or condition other than geographic atrophy secondary to age-related macular degeneration.
- Diagnosis or history of exudative AMD, macular neovascularization, or retinal angiomatous proliferation.
- Active ocular or periocular infection or uncontrolled intraocular inflammation within 3 months before screening.
- History of vitrectomy, retinal detachment, or corneal transplant in the study eye.
- Active or history of uveitis.
- Any ocular condition preventing adequate imaging.
- Medical, cognitive, or psychiatric conditions that may interfere with study assessments or increase risk.
- Hospitalization within 1 year prior to screening that affects assessment or risk.
- Clinically significant abnormal screening tests or lab values.
- Contraindication to steroid regimen or conditions increasing risk of complications.
- Active or history of malignancy within 5 years, except certain skin or localized cancers.
- Intraocular surgery within 3 months prior to screening.
- History of laser therapy in the macular region.
- Intravitreal steroid therapy within 6 months prior to screening.
- COVID-19 vaccination within 90 days before screening or planned vaccination within 6 months after treatment.
- Active use of systemic immunomodulatory drugs or corticosteroids in the last 60 days.
- Prior participation in another interventional GA clinical study within 12 months prior to screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day injection with medication use for several weeks after dosing
Participants receive a single suprachoroidal injection of VV-14295 along with oral prednisone and eye drops before and after dosing to reduce inflammation. After several weeks, participants switch to a different eye drop medication.
1 baseline visit and multiple follow-up visits over 12 months
Duration - Up to 12 months
Participants are monitored for safety and efficacy outcomes including ocular health, visual function preservation, and immune response for up to 12 months after treatment.
Multiple visits at 3, 6, and 12 months post-treatment
Trial Site Locations
Total: 3 locations
1
Kriya Clinical Study Site
Ottawa, Ontario, Canada
Actively Recruiting
2
Kriya Clinical Study Site
Tel Aviv, Israel
Actively Recruiting
3
Kriya Clinical Study Site
Christchurch, New Zealand
Actively Recruiting
Research Team
V
VP, Medical Affairs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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