62 Participants Needed

KRIYA-825 for Macular Degeneration

(VISION Trial)

Recruiting at 2 trial locations
DM
VM
Overseen ByVP, Medical Affairs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of KRIYA-825, a new treatment designed to slow the growth of geographic atrophy (GA) lesions in individuals with age-related macular degeneration (AMD), which affects vision. Participants will receive a dose of KRIYA-825 (also known as VV-14295), along with oral and eye drop steroids to reduce inflammation. Ideal candidates are those diagnosed with GA due to AMD who experience significant vision issues in one eye but do not have other active eye diseases. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Is there any evidence suggesting that KRIYA-825 (VV-14295) is likely to be safe for humans?

Research shows that KRIYA-825 (VV-14295) is under evaluation for its safety and tolerability in treating age-related macular degeneration (AMD). In earlier studies, patients generally tolerated the treatment well. However, side effects can occur with any new treatment. Some participants experienced changes in their health, but these were mostly manageable. Additional medications, such as prednisone and eye drops, help reduce the risk of inflammation, a common concern with treatments like this. Overall, while potential risks exist, researchers carefully monitor the treatment to ensure participants' safety.12345

Why do researchers think this study treatment might be promising for macular degeneration?

Most treatments for macular degeneration, like anti-VEGF injections, focus on slowing vision loss by targeting blood vessel growth in the eye. But KRIYA-825 (VV-14295) offers a fresh approach. This treatment works by delivering a single dose intended to manage inflammation directly, potentially reducing the need for frequent eye injections. Researchers are excited about this because it combines the novel mechanism with ease of use, offering a promising alternative to the regular regimens currently available.

What evidence suggests that KRIYA-825 could be effective for macular degeneration?

Research has shown that KRIYA-825, the investigational treatment in this trial, may help treat macular degeneration by maintaining the health of the retina, the part of the eye responsible for vision. In animal studies, this treatment reduced certain harmful proteins in the eye, suggesting it might slow the damage caused by the disease. KRIYA-825 is a type of gene therapy designed to protect the eye from further deterioration. Although more information is needed from human studies, these early results indicate that KRIYA-825 could potentially slow the progression of damaged areas in the eyes of patients with age-related macular degeneration.12467

Are You a Good Fit for This Trial?

This trial is for adults aged 55-80 with geographic atrophy due to age-related macular degeneration. Participants must not be pregnant or breastfeeding, have clear eyes and good pupil dilation for imaging, a specific level of vision loss in the affected eye, and a BMI between 19-34 kg/m2.

Inclusion Criteria

I agree to use birth control for 12 months after treatment and am not pregnant or breastfeeding.
My BMI is between 19 and 34.
My eye condition has been confirmed by a special eye imaging test.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

A single dose of VV-14295 is administered with oral prednisone and difluprednate eye drops to reduce inflammation, followed by a switch to prednisolone acetate eye drops

Several weeks

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and visual function preservation

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • KRIYA-825 (VV-14295)
Trial Overview The study tests KRIYA-825 (VV-14295) for safety, tolerability, and effectiveness in slowing down the growth of lesions caused by geographic atrophy in patients with age-related macular degeneration.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment1 Intervention
Group II: Part 1bExperimental Treatment1 Intervention
Group III: Part 1a, low doseExperimental Treatment1 Intervention
Group IV: Part 1a, high doseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kriya Therapeutics, Inc.

Lead Sponsor

Trials
1
Recruited
60+

Citations

A Study to Evaluate KRIYA-825 (VV-14295) in Adults With ...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 ...
A Study to Evaluate KRIYA-825 (VV-14295) in Adults with ...Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...
KRIYA-825 gene therapy data announcedKRIYA-825 treated mice demonstrated dose-dependent preservation of retinal thickness. · Retinal damage caused by NaIO 3 increased C3b fragment ...
A Study to Evaluate KRIYA-825 (VV-14295) in Adults With ...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 ...
A Novel AAV Gene Therapy Complement Inhibitor: KRIYA-825 ...Retinal damage by NaIO3 increased C3b and iC3b fragments, while KRIYA-825 treatment reduced iC3b protein levels comparable to naïve animals. In NHPs, the ...
actrn12625000877482Presence of an active ocular disease that in the opinion of the investigator compromises or confounds visual function and retinal image quality.
VV-14295 for Geographic Atrophy in Age-related Macular ...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 ...
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