NCT06087458

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
21mo left

Started Jun 2023

Longer than P75 for phase_1

Geographic Reach
3 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jun 2023Mar 2028

Study Start

First participant enrolled

June 21, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

October 15, 2025

Status Verified

September 1, 2025

Enrollment Period

3.9 years

First QC Date

October 12, 2023

Last Update Submit

October 13, 2025

Conditions

Age-Related Macular DegenerationGeographic AtrophyNon-neovascular AMD

Outcome Measures

Primary Outcomes (1)

  • Overall effect of treatment on retinal structural health

    GA growth rate and Change in Ellipsoid Zone Integrity

    Week 48

Secondary Outcomes (4)

  • Overall effect of treatment on retinal structural health

    Weeks 36, 48, and 96

  • Effect of treatment on vision function

    Change from baseline

  • Incidence of neovascular AMD

    Baseline to Week 96

  • VOY-101 Safety

    Baseline to Week 96

Study Arms (2)

VOY-101

EXPERIMENTAL

Single intravitreal injection of VOY-101

Biological: VOY-101

Controll

NO INTERVENTION

Fellow Eye

Interventions

VOY-101BIOLOGICAL

VOY-101

VOY-101

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Meet certain genotype criteria for risk of AMD.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Retina Macula Institute of AZ

Scottsdale, Arizona, 85255, United States

RECRUITING

The Retina Partners

Encino, California, 91436, United States

RECRUITING

Retinal Consultants Medical Group

Sacramento, California, 95825, United States

RECRUITING

Retina Consultants San Diego

San Diego, California, 92064, United States

RECRUITING

Star Retina

Burleson, Texas, 76028, United States

RECRUITING

Retina Center of Texas

Southlake, Texas, 76092, United States

RECRUITING

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

RECRUITING

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, 2000, Australia

ACTIVE NOT RECRUITING

Cerulea Clinical Trials

East Melbourne, Victoria, 3002, Australia

ACTIVE NOT RECRUITING

Rambam Medical Center

Haifa, Israel

RECRUITING

Tel-Aviv Sourasky Medical Center, Ophthalmology Division

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Macular DegenerationGeographic Atrophy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Anne Fung, MD

    Perceive Biotherapeutics, Inc.

    STUDY DIRECTOR

Central Study Contacts

Anne Fung, MD

CONTACT

(800) 867-7960Voy101clinical@perceivebio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Central Reading Center is masked.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Phase 1 follows a standard dose escalation model to evaluate safety and tolerability of VOY-101 and recommended Phase 2a dose (RP2D). This dose will be used in Phase 2a to evaluate the safety and efficacy of VOY-101 in the study eye compared to untreated fellow eye.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 17, 2023

Study Start

June 21, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

October 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(7)AU(2)IL(2)