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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06765980




Registration number
NCT06765980
Ethics application status
Date submitted
19/12/2024
Date registered
9/01/2025
Date last updated
14/01/2025

Titles & IDs
Public title
A Study to Evaluate KRIYA-825 (VV-14295) in Adults with Geographic Atrophy Secondary to Age-related Macular Degeneration
Scientific title
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)
Secondary ID [1] 0 0
KRIYA-825-101
Universal Trial Number (UTN)
Trial acronym
VISION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy Secondary to Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - VV-14295

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.


Treatment: Other: VV-14295
VV-14295 will be administered as a single suprachoroidal injection.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Rate of GA progression as assessed by optical coherence tomography (OCT)
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
Rate of GA progression as assessed by fundus autofluorescence (FAF)
Timepoint [1] 0 0
3, 6, and 12 months
Secondary outcome [2] 0 0
Rate of GA progression as assessed by OCT
Timepoint [2] 0 0
3, 6, and 12 months
Secondary outcome [3] 0 0
Visual function preservation as assessed by best-corrected visual acuity (BCVA)
Timepoint [3] 0 0
3, 6, and 12 months
Secondary outcome [4] 0 0
Visual function preservation as assessed by low luminance visual acuity (LLVA)
Timepoint [4] 0 0
3, 6, and 12 months
Secondary outcome [5] 0 0
Visual function preservation as assessed by microperimetry
Timepoint [5] 0 0
3, 6, and 12 months
Secondary outcome [6] 0 0
VV-14295 transgene product expression
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Immune response to VV-14295
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Vector shedding profile of VV-14295
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Safety of Everads Injector
Timepoint [9] 0 0
1 day post-dose

Eligibility
Key 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.
Minimum age
55 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
9/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2027
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kriya Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT06765980
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dan Manning
Address 0 0
Country 0 0
Phone 0 0
650-268-4273
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06765980