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Clinical Trials in Australia / NCT06087458
Active, not recruiting Phase 1/2

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

NCT06087458 · tracked via the Priya Life Science Australia tracker
Sponsor
Perceive Biotherapeutics, Inc
Phase
Phase 1/2
Started
2023-06-21
Last updated
2026-08-17

Condition(s) studied

Age-Related Macular DegenerationGeographic AtrophyNon-neovascular AMDNon-neovascular Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

VOY-101 →

VOY-101: VOY-101

Study summary

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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Phase 1: To evaluate the safety and tolerability of a single intravitreal injection of escalating doses of VOY-101 — 24 Months
    Frequency and type of ocular and systemic adverse events and non-serious treatment-emergent adverse events
  • Phase 1: Change from Baseline in markers of inflammation — Baseline to Month 24
    Change from Baseline in markers of inflammation including anterior chamber cells, vitreous cells, and retinal vasculitis and retinitis.
  • Phase 1: Establish the recommended Phase 2 dose in subjects with Geographic Atrophy. — 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.
  • 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. — 15 Months
    Change from Baseline in Geographic Atrophy lesion size

Trial sites (16)

FacilityCityRegionStatus
Retina Macula Institute of AZ Scottsdale Arizona
Retina Consultants San Diego Poway California
Retinal Consultants Medical Group Sacramento California
Ophthalmic Consultants of Boston Boston Massachusetts
The Retina Institute St Louis Missouri
Mid Atlantic Retina Cherry Hill New Jersey
Retina Northwest Portland Oregon
Black Hills Regional Eye Institute Rapid City South Dakota
Austin Research Center for Retina Austin Texas
Star Retina Fort Worth Texas
Retina Center of Texas Southlake Texas
University of Utah John A. Moran Eye Center Salt Lake City Utah
Sydney Retina Clinic and Day Surgery Sydney New South Wales
Cerulea Clinical Trials East Melbourne Victoria
Rambam Medical Center Haifa Israel
Tel-Aviv Sourasky Medical Center, Ophthalmology Division Tel Aviv Israel

Other trials for the same condition

A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Recruiting
Defining Retinal Structures Using Hyperspectral Retinal Imaging Recruiting
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) Recruiting
A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) Active, not recruiting
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06087458 on ClinicalTrials.gov ↗ ← All trials in Australia