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Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

PHASE1PHASE2RECRUITING

The Phase 1 safety study of VOY-101 comprises of escalating dose Cohorts, followed by a Phase 2a.

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Study details:

This is a prospective, open-label, multi-center Phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of escalating dose levels of VOY-101 therapy in subjects with advanced non-neovascular age-related macular degeneration (AMD).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Are ≥50 years of age at the time of consent.
  • Are willing and able to understand and provide written informed consent.
  • Are willing and able to return for scheduled treatment and follow-up examinations.
  • Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.
  • Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV.
  • Absence of signs of non-exudative MNV.
  • Additional Ocular Inclusion Criteria for study eye.
  • Meet certain genotype criteria for risk of AMD.
  • Exclusion criteria

  • Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study.
  • Additional Systemic, Ocular, and Genetic Exclusion Criteria.
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    Eligibility

    Age eligible for study : 50 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-06-21

    Primary completion: 2026-10-01

    Study completion finish: 2027-10-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT06087458

    Intervention or treatment

    BIOLOGICAL: VOY-101

    Conditions

    • Age-Related Macular Degeneration

    Find a site

    Closest Location:

    Sydney Retina Clinic and Day Surgery

    Research sites nearby

    Select from list below to view details:

    • Sydney Retina Clinic and Day Surgery

      Sydney, New South Wales, Australia

    • Cerulea Clinical Trials

      East Melbourne, Victoria, Australia

    • Cabrini Research

      Melbourne, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Experimental: Low
    • Single intravitreal injection of VOY-101
    BIOLOGICAL: VOY-101
    • VOY-101
    EXPERIMENTAL: Experimental: Medium
    • Single intravitreal injection of VOY-101
    BIOLOGICAL: VOY-101
    • VOY-101
    EXPERIMENTAL: Experimental: High
    • Single intravitreal injection of VOY-101
    BIOLOGICAL: VOY-101
    • VOY-101
    EXPERIMENTAL: Experimental: Higher
    • Single intravitreal injection of VOY-101
    BIOLOGICAL: VOY-101
    • VOY-101

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Safety and Tolerability as measured by frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])Not Specified24 months

    Secondary outcome

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

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