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

August 12, 2026 updated by: Perceive Biotherapeutics, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Sydney Retina Clinic and Day Surgery
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Cerulea Clinical Trials
  • Israel
      • Haifa, Israel
        • Rambam Medical Center
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center, Ophthalmology Division
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Retina Macula Institute of AZ
    • California
      • Poway, California, United States, 92064
        • Retina Consultants San Diego
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Missouri
      • St Louis, Missouri, United States, 63128
        • The Retina Institute
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08034
        • Mid Atlantic Retina
    • Oregon
      • Portland, Oregon, United States, 97221
        • Retina Northwest
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Research Center for Retina
      • Fort Worth, Texas, United States, 76132
        • Star Retina
      • Southlake, Texas, United States, 76092
        • Retina Center Of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah John A. Moran Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low
Single, unilateral, intravitreal injection of low dose of VOY-101
Biological: VOY-101
VOY-101
Experimental: Medium
Single, unilateral, intravitreal injection of medium dose of VOY-101
Biological: VOY-101
VOY-101
Experimental: High
Single, unilateral, intravitreal injection of high dose of VOY-101
Biological: VOY-101
VOY-101
Experimental: Higher
Single, unilateral, intravitreal injection of higher dose of VOY-101
Biological: VOY-101
VOY-101
Experimental: Intermediate
Single, unilateral, intravitreal injection of intermediate dose of VOY-101
Biological: VOY-101
VOY-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 Months
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.
Baseline to Month 24
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.
Month 12
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
15 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline through 24 Months
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
Baseline through 24 Months
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
24 Months
Phase 1/2: Development of macular neovascularization
Time Frame: Month 24
Incidence, frequency, severity, and timing of development of macular neovascularization
Month 24
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.
24 Months
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
Baseline through Month 24
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
Baseline through Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perceive Biotherapeutics, Inc.

Investigators

  • Study Director: Anne Fung, MD, Perceive Biotherapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBI-AMD-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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