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Active, not recruiting

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 is comprised of escalating dose Cohorts, followed by a Phase 2 at the recommended phase 2 dose.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Geographic Atrophy Macular Degeneration Non-Neovascular Age-Related 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

The study has a prospective, open-label, multi-center, two-part design to evaluate a single, unilateral intravitreal (IVT) injection of VOY-101 in subjects with geographic atrophy (GA), the advanced form of non-neovascular age-related macular degeneration (AMD). Phase 1 followed a standard dose escalation model to establish safety and tolerability of VOY-101 and determine the recommended phase 2 dose. This dose is being used in the randomized Phase 2 part of the study to evaluate the safety and efficacy of VOY-101 in the study eye compared to untreated fellow eye.

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. Phase 1: To evaluate the safety and tolerability of a single intravitreal injection of escalating doses of VOY-101

    Time frame: 24 Months

    Frequency and type of ocular and systemic adverse events and non-serious treatment-emergent adverse events

  2. Phase 1: Change from Baseline in markers of inflammation

    Time frame: Baseline to Month 24

    Change from Baseline in markers of inflammation including anterior chamber cells, vitreous cells, and retinal vasculitis and retinitis.

  3. Phase 1: Establish the recommended Phase 2 dose in subjects with Geographic Atrophy.

    Time frame: Month 12

    Determine whether the maximum tolerated dose (MTD) has been reached (as determined by the occurrence of dose-limiting toxicities [DLTs]) and select the RP2D.

  4. Phase 2: To evaluate the effect of VOY-101 in the study eye compared with untreated fellow eye on change in Geographic Atrophy lesion size.

    Time frame: 15 Months

    Change from Baseline in Geographic Atrophy lesion size

Secondary outcomes

  1. Phase 1: To evaluate the effect of VOY-101 on geographic atrophy lesion size and photoreceptors

    Time frame: Baseline through 24 Months

    Growth rate of total geographic atrophy lesion size and photoreceptor change

  2. Phase 1/2: To establish the pharmacokinetic (PK) profile of VOY-101.

    Time frame: Baseline through 24 Months

    Change from Baseline for complement levels in aqueous humor

  3. Phase 1/2: To evaluate the effect of VOY-101 on best corrected distance visual acuity

    Time frame: 24 Months

    Change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCDVA and Percentage of subjects with <15 letters lost in BCDVA from Treatment

  4. Phase 1/2: Development of macular neovascularization

    Time frame: Month 24

    Incidence, frequency, severity, and timing of development of macular neovascularization

  5. Phase 2: To further characterize the ocular and systemic safety and tolerability of VOY-101

    Time frame: 24 Months

    Frequency of Investigational Product related ocular and systemic adverse events, adverse events of special interest and non-serious treatment-emergent adverse events.

  6. Phase 2: To evaluate the effect of VOY-101 in the study eye compared with untreated fellow eye on geographic atrophy lesion size and photoreceptors

    Time frame: Baseline through Month 24

    Change in geographic atrophy lesion size and rate of photoreceptor loss

  7. Phase 2: To evaluate the effect of VOY-101 on low luminance visual acuity

    Time frame: Baseline through Month 24

    Change from Baseline in the change in visual function using Early Treatment Diabetic Retinopathy Study (ETDRS) Low Luminance Visual (LLVA) vision test

Sponsors and collaborators

Lead sponsor

Perceive Biotherapeutics, Inc.

Industry

Registry information

Official study title

Phase 1/2a Study of VOY-101 in Subjects With Advanced Non-Neovascular Age-Related Macular Degeneration (JOURNEY)

Acronym: JOURNEY

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 17, 2023
Registry last updated
Aug 17, 2026

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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