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VISION

VV-14295 for Geographic Atrophy in Age-related Macular Degeneration

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What is being tested

VV-14295

Genetic
Who is being recruted

Geographic Atrophy Secondary to Age-related Macular Degeneration

From 55 to 80 Years
+20 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2025

See protocol details

Summary

Principal SponsorKriya Therapeutics, Inc.
Study ContactVP, Medical Affairs
Last updated: September 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: May 28, 2025Actual date on which the first participant was enrolled.

This study aims to assess the safety and effectiveness of a new treatment called KRIYA-825 (VV-14295) for individuals with a specific eye condition known as geographic atrophy (GA) caused by age-related macular degeneration (AMD). Geographic atrophy is a serious condition leading to vision loss in older adults, and there is a significant need for treatments that can slow down or stop its progression. By testing this treatment, the study hopes to find a potential way to reduce the growth of GA lesions, which are damaged areas in the eye that worsen over time. Participants in the study will receive the KRIYA-825 treatment through a method called suprachoroidal injection, using a special device called the Everads Injector. This way of delivering the treatment targets the affected areas in the eye more directly. The study will focus on observing the safety and tolerability of the treatment, which means checking for any side effects or discomforts, and evaluating its effectiveness in slowing down the growth of GA lesions. While the study does not list specific outcomes, it is an important step in finding a treatment for those suffering from this vision-threatening condition.

Official TitleA 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) 
Principal SponsorKriya Therapeutics, Inc.
Study ContactVP, Medical Affairs
Last updated: September 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
62 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 55 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Geographic Atrophy Secondary to Age-related Macular Degeneration
Criteria
7 inclusion criteria required to participate
Body mass index (BMI) of 19 to 34 kg/m2 (inclusive).
Participant must be between 55 to 80 years of age (inclusive), at the time of signing the informed consent form.
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.
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.

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13 exclusion criteria prevent from participating
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.
Active use of systemic immunomodulatory drugs or systemic corticosteroids in the last 60 days. Topical steroids are not exclusionary.
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.
Prior participation in another interventional clinical study for GA within the past 12 months from the last dosing at Screening.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
4 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Group II
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.
Group III
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.
Group IV
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.
Study Objectives
Primary Objectives

Evaluate Part 1 safety of VV-14295 in foveal and non-foveal patients

Evaluate Part 2 safety of VV-14295 in non-foveal GA patients

Part 2 efficacy of VV-14295
Secondary Objectives

Parts 1 and 2 efficacy of VV-14295

Parts 1 and 2 efficacy of VV-14295

Parts 1 and 2 efficacy of VV-14295

Parts 1 and 2 efficacy of VV-14295

Parts 1 and 2 efficacy of VV-14295

Concentrations of AAV vector-mediated transgene product in serum

Humoral and cellular responses to AAV2 capsid and transgene product; anti-AAV2 neutralization capacity in serum

Vector shedding in serum, tears, mucus, and urine

Frequency of device-related adverse events and serious adverse events

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Kriya Clinical Study SiteChristchurch, New ZealandSee the location
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One Study Center