Geographic Atrophy Secondary to Age-related Macular DegenerationPhase 1/2VISIONNCT06765980
A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration
A Phase 1/2 study testing VV-14295 in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Kriya Therapeutics, Inc. at 4 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Geographic Atrophy Secondary to Age-related Macular Degeneration
- What is being tested?
- VV-14295
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 28 May 2025to 15 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
United States1 site, 1 recruiting
- Recruiting
Kriya Clinical Study Site
Erie, Pennsylvania, 16505
VP, Medical Affairs, 984-884-5058, clinicaltrials@kriyatx.com
Canada1 site, 1 recruiting
- Recruiting
Kriya Clinical Study Site
Ottawa, Ontario
VP, Medical Affairs, 984-884-5058, clinicaltrials@kriyatx.com
Israel1 site, 1 recruiting
- Recruiting
Kriya Clinical Study Site
Tel Aviv
VP, Medical Affairs, 984-884-5058, clinicaltrials@kriyatx.com
New Zealand1 site, 1 recruiting
- Recruiting
Kriya Clinical Study Site
Christchurch
About this study
Official 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)
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).
- Being tested
- VV-14295
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VV-14295Genetic
VV-14295 will be administered as a single suprachoroidal injection.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a, low dose | Experimental | 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. Receives: Genetic: VV-14295 |
| Part 1a, high dose | Experimental | 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. Receives: Genetic: VV-14295 |
| Part 1b | Experimental | 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. Receives: Genetic: VV-14295 |
| Part 2 | Experimental | 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. Receives: Genetic: VV-14295 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Evaluate Part 1 safety of VV-14295 in foveal and non-foveal patients
Measured: 12 months
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
Evaluate Part 2 safety of VV-14295 in non-foveal GA patients
Measured: 12 months
Rate of GA progression as assessed by optical coherence tomography (OCT)
Part 2 efficacy of VV-14295
Measured: 12 months
Secondary outcomes (9)
Rate of GA progression as assessed by fundus autofluorescence (FAF)
Parts 1 and 2 efficacy of VV-14295
Measured: 3, 6, and 12 months
Rate of GA progression as assessed by OCT
Parts 1 and 2 efficacy of VV-14295
Measured: 3, 6, and 12 months
Visual function preservation as assessed by best-corrected visual acuity (BCVA)
Parts 1 and 2 efficacy of VV-14295
Measured: 3, 6, and 12 months
Visual function preservation as assessed by low luminance visual acuity (LLVA)
Parts 1 and 2 efficacy of VV-14295
Measured: 3, 6, and 12 months
Visual function preservation as assessed by microperimetry
Parts 1 and 2 efficacy of VV-14295
Measured: 3, 6, and 12 months
VV-14295 transgene product expression
Concentrations of AAV vector-mediated transgene product in serum
Measured: 12 months
Immune response to VV-14295
Humoral and cellular responses to AAV2 capsid and transgene product; anti-AAV2 neutralization capacity in serum
Measured: 12 months
Vector shedding profile of VV-14295
Vector shedding in serum, tears, mucus, and urine
Measured: 12 months
Safety of Everads Injector
Frequency of device-related adverse events and serious adverse events
Measured: 1 day post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start28 May 2025
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic Atrophy Secondary to Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kriya Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765980
- Sponsor's protocol ID
- KRIYA-825-101
- Acronym
- VISION
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06765980
- Acronym / sponsor ID
- VISION / KRIYA-825-101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Kriya Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 May 2025 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1a, low dose | Experimental | Genetic: VV-14295A 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. |
| Part 1a, high dose | Experimental | Genetic: VV-14295A 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. |
| Part 1b | Experimental | Genetic: VV-14295A 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. |
| Part 2 | Experimental | Genetic: VV-14295A 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VV-14295VV-14295 will be administered as a single suprachoroidal injection. | Genetic | Part 1a, high dose, Part 1a, low dose, Part 1b, Part 2 |
Primary outcome
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
Evaluate Part 1 safety of VV-14295 in foveal and non-foveal patients
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
Evaluate Part 2 safety of VV-14295 in non-foveal GA patients
Rate of GA progression as assessed by optical coherence tomography (OCT)
Time frame: 12 months
Part 2 efficacy of VV-14295
9 secondary outcomes
Rate of GA progression as assessed by fundus autofluorescence (FAF)
Time frame: 3, 6, and 12 months
Rate of GA progression as assessed by OCT
Time frame: 3, 6, and 12 months
Visual function preservation as assessed by best-corrected visual acuity (BCVA)
Time frame: 3, 6, and 12 months
Visual function preservation as assessed by low luminance visual acuity (LLVA)
Time frame: 3, 6, and 12 months
Visual function preservation as assessed by microperimetry
Time frame: 3, 6, and 12 months
VV-14295 transgene product expression
Time frame: 12 months
Immune response to VV-14295
Time frame: 12 months
Vector shedding profile of VV-14295
Time frame: 12 months
Safety of Everads Injector
Time frame: 1 day post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VV-14295 in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Kriya Therapeutics, Inc. at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada, Israel, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VP, Medical Affairs (984-884-5058, clinicaltrials@kriyatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.