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NCT Number: NCT06087458

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

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

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Geographic Atrophy Macular Degeneration Non-neovascular AMD Retinal Degeneration Retinal Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sydney Retina Clinic and Day Surgery, Sydney, New South Wales, Australia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are ≥60 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 for both eyes.
  • Absence of signs of non-exudative MNV.
  • Additional Ocular Inclusion Criteria for both eyes.
  • 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.

Treatment and study plan

VOY-101

Biological

VOY-101

Primary outcomes

  1. Overall effect of treatment on retinal structural health

    Time frame: Week 48

    GA growth rate and Change in Ellipsoid Zone Integrity

Secondary outcomes

  1. Overall effect of treatment on retinal structural health

    Time frame: Weeks 36, 48, and 96

    GA Growth Rate and Change in Ellipsoid Zone Integrity

  2. Effect of treatment on vision function

    Time frame: Change from baseline

    Change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCDVA and LLVA and microperimetry.

  3. Incidence of neovascular AMD

    Time frame: Baseline to Week 96

    Incidence, frequency, severity, and timing of development of neovascular AMD

  4. VOY-101 Safety

    Time frame: Baseline to Week 96

    Frequency of related ocular and systemic AEs (SAEs and non-serious), adverse events of special interest (AESI) and non-serious TEAEs).

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Fung, MD

CONTACT

[email protected]

(800) 867-7960

Sponsors and collaborators

Lead sponsor

Perceive Biotherapeutics, Inc.

Industry

Registry information

Official study title

Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non- Neovascular Age-Related Macular Degeneration

Acronym: JOURNEY

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 17, 2023
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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