A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration (VISION)
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)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: VP, Medical Affairs
- Phone Number: 984-884-5058
- Email: clinicaltrials@kriyatx.com
Study Locations
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Ontario
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Ottawa, Ontario, Canada
- Recruiting
- Kriya Clinical Study Site
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Contact:
- VP, Medical Affairs
- Phone Number: 984-884-5058
- Email: clinicaltrials@kriyatx.com
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Tel Aviv, Israel
- Recruiting
- Kriya Clinical Study Site
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Contact:
- VP, Medical Affairs
- Phone Number: 984-884-5058
- Email: clinicaltrials@kriyatx.com
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Christchurch, New Zealand
- Recruiting
- Kriya Clinical Study Site
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Pennsylvania
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Erie, Pennsylvania, United States, 16505
- Recruiting
- Kriya Clinical Study Site
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Contact:
- VP, Medical Affairs
- Phone Number: 984-884-5058
- Email: clinicaltrials@kriyatx.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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.
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VV-14295 will be administered as a single suprachoroidal injection.
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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.
|
VV-14295 will be administered as a single suprachoroidal injection.
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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.
|
VV-14295 will be administered as a single suprachoroidal injection.
|
|
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.
|
VV-14295 will be administered as a single suprachoroidal injection.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Evaluate Part 1 safety of VV-14295 in foveal and non-foveal patients
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12 months
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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
Time Frame: 12 months
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Evaluate Part 2 safety of VV-14295 in non-foveal GA patients
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12 months
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Rate of GA progression as assessed by optical coherence tomography (OCT)
Time Frame: 12 months
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Part 2 efficacy of VV-14295
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12 months
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of GA progression as assessed by fundus autofluorescence (FAF)
Time Frame: 3, 6, and 12 months
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Parts 1 and 2 efficacy of VV-14295
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3, 6, and 12 months
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Rate of GA progression as assessed by OCT
Time Frame: 3, 6, and 12 months
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Parts 1 and 2 efficacy of VV-14295
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3, 6, and 12 months
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Visual function preservation as assessed by best-corrected visual acuity (BCVA)
Time Frame: 3, 6, and 12 months
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Parts 1 and 2 efficacy of VV-14295
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3, 6, and 12 months
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Visual function preservation as assessed by low luminance visual acuity (LLVA)
Time Frame: 3, 6, and 12 months
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Parts 1 and 2 efficacy of VV-14295
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3, 6, and 12 months
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Visual function preservation as assessed by microperimetry
Time Frame: 3, 6, and 12 months
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Parts 1 and 2 efficacy of VV-14295
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3, 6, and 12 months
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VV-14295 transgene product expression
Time Frame: 12 months
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Concentrations of AAV vector-mediated transgene product in serum
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12 months
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Immune response to VV-14295
Time Frame: 12 months
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Humoral and cellular responses to AAV2 capsid and transgene product; anti-AAV2 neutralization capacity in serum
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12 months
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Vector shedding profile of VV-14295
Time Frame: 12 months
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Vector shedding in serum, tears, mucus, and urine
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12 months
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Safety of Everads Injector
Time Frame: 1 day post-dose
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Frequency of device-related adverse events and serious adverse events
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1 day post-dose
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- KRIYA-825-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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