Evaluating KRIYA-825 for treating geographic atrophy in older adults

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)

This study is testing a new treatment called KRIYA-825 to see if it can safely help older adults with geographic atrophy from age-related macular degeneration by slowing down the growth of eye lesions.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 55 Years to 80 Years
• Sex: All
• Sponsor: Kriya Therapeutics, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 3 sites (Ottawa, Ontario and 2 other locations)
• Trial ID: NCT06765980 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of KRIYA-825 (VV-14295) in adults aged 55 to 80 with geographic atrophy secondary to age-related macular degeneration. It will also evaluate the effectiveness of this treatment in reducing the growth of geographic atrophy lesions in the affected eye. Participants will undergo imaging assessments to ensure eligibility based on specific criteria related to their condition. The study is designed to gather data on both the safety profile and the potential benefits of KRIYA-825 for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 55 to 80 with specific visual acuity criteria and geographic atrophy due to age-related macular degeneration.

Not a fit: Patients with other significant ocular conditions or those outside the specified age and visual acuity criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could slow the progression of geographic atrophy, potentially preserving vision for patients.

How similar studies have performed: While this approach is being evaluated, similar studies targeting geographic atrophy have shown promise, but the specific treatment KRIYA-825 is novel.

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.

Where this trial is running

Ottawa, Ontario and 2 other locations

• Kriya Clinical Study Site — Ottawa, Ontario, Canada (Recruiting)
• Kriya Clinical Study Site — Tel Aviv, Israel (Recruiting)
• Kriya Clinical Study Site — Christchurch, New Zealand (Recruiting)

Study contacts

• Study coordinator: VP, Medical Affairs

Conditions Geographic Atrophy Secondary to Age-related Macular Degeneration