A Study to Evaluate KRIYA-825 (VV-14295) in Adults with Geographic Atrophy Secondary to Age-related Macular Degeneration

Last updated: March 20, 2025
Sponsor: Kriya Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Geographic Atrophy

Macular Degeneration

Neoplasm Metastasis

Treatment

VV-14295

Clinical Study ID

NCT06765980
KRIYA-825-101
  • Ages 55-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be between 55 to 80 years of age (inclusive), at the time ofsigning 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 administrationof VV-14295. A female participant is eligible to participate if she is not pregnantand not breastfeeding.

  • The GA lesion must meet certain criteria as assessed by a central reading center'sassessment of imaging at Screening.

  • Adequate clarity of ocular media, adequate pupillary dilation, and fixation topermit 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 (20/800or better) for Part 1a participants or 24 letters or better (approximately 20/320Snellen equivalent or better) for Part 1b and Part 2 participants. Fellow eye musthave equivalent or better visual acuity than the study eye.

Exclusion

Exclusion Criteria:

  • Any ocular disease or condition that is not GA secondary to AMD: Macular atrophysecondary to a condition other than AMD; Exudative AMD diagnosis or any history ofor active macular neovascularization (in study eye or fellow eye) and/or retinalangiomatous proliferation associated with AMD or any other cause; Presence of anactive ocular disease that in the opinion of the Investigator compromises orconfounds visual function; Active ocular or periocular infection or activeuncontrolled intraocular inflammation within 3 months of Screening; History ofvitrectomy, 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 theInvestigator, make consistent study assessment and follow-up over the 12-monthPost-Treatment Follow-up Period unlikely, or could increase the risk to theparticipant by participating in the study or confound the outcome of the study.

  • Hospitalization within 1 year prior to Screening that, in the opinion of theInvestigator, make consistent study assessment and follow-up over the 12-monthPost-Treatment Follow-up Period unlikely, or could increase the risk to theparticipant 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 theopinion of the Investigator and/or Medical Monitor is clinically significant andrenders the participant not suitable for study participation.

  • Participant has a direct contraindication to the steroid regimen (both oral andtopical) or has a condition that significantly increases the risk of complication.

  • Active/history of malignancy within the past 5 years from Screening or any previoustherapeutic radiation in the region of the study eye(s) at Screening. History ofnon-melanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervicalintraepithelial neoplasia (CIN), and localized prostate cancer after treatment arenot exclusionary.

  • Intraocular surgery (including lens replacement surgery) within 3 months prior toScreening.

  • History of laser therapy in the macular region.

  • History of intravitreal (IVT) therapy, such as IVT steroid injections, within 6months prior to Screening.

  • COVID-19 vaccine within 90 days of Screening or plan to receive COVID-19 vaccinewithin 6 months of treatment.

  • Active use of systemic immunomodulatory drugs or systemic corticosteroids in thelast 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

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: VV-14295
Phase: 1/2
Study Start date:
March 01, 2025
Estimated Completion Date:
December 15, 2027

Connect with a study center

  • Kriya Clinical Study Site

    Christchurch,
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research (NZCR)

    Christchurch,
    New Zealand

    Active - Recruiting

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