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

October 13, 2025 updated by: Perceive Biotherapeutics, Inc.

Phase 1/2a Dose Escalation 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

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 Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Active, not recruiting
        • Sydney Retina Clinic and Day Surgery
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Active, not recruiting
        • Cerulea Clinical Trials
  • Israel
      • Haifa, Israel
        • Recruiting
        • Rambam Medical Center
        • Contact:
          • Meital Abecassis
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel-Aviv Sourasky Medical Center, Ophthalmology Division
        • Contact:
          • Adi Riza
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Recruiting
        • Retina Macula Institute of AZ
    • California
      • Encino, California, United States, 91436
        • Recruiting
        • The Retina Partners
      • Sacramento, California, United States, 95825
        • Recruiting
        • Retinal Consultants Medical Group
      • San Diego, California, United States, 92064
        • Recruiting
        • Retina Consultants San Diego
    • Texas
      • Burleson, Texas, United States, 76028
        • Recruiting
        • Star Retina
      • Southlake, Texas, United States, 76092
        • Recruiting
        • Retina Center Of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VOY-101
Single intravitreal injection of VOY-101
Biological: VOY-101
VOY-101
No Intervention: Controll
Fellow Eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall effect of treatment on retinal structural health
Time Frame: Week 48
GA growth rate and Change in Ellipsoid Zone Integrity
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall effect of treatment on retinal structural health
Time Frame: Weeks 36, 48, and 96
GA Growth Rate and Change in Ellipsoid Zone Integrity
Weeks 36, 48, and 96
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.
Change from baseline
Incidence of neovascular AMD
Time Frame: Baseline to Week 96
Incidence, frequency, severity, and timing of development of neovascular AMD
Baseline to Week 96
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).
Baseline to Week 96

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)

June 1, 2027

Study Completion (Estimated)

March 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 (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

October 13, 2025

Last Verified

September 1, 2025

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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