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

NCT ID: NCT06087458

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-21

Study Completion Date

2028-03-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Age-Related Macular Degeneration Geographic Atrophy Non-neovascular AMD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Central Reading Center is masked.

Study Groups

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VOY-101

Single intravitreal injection of VOY-101

Group Type EXPERIMENTAL

VOY-101

Intervention Type BIOLOGICAL

VOY-101

Controll

Fellow Eye

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VOY-101

VOY-101

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
* 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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Perceive Biotherapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Fung, MD

Role: STUDY_DIRECTOR

Perceive Biotherapeutics, Inc.

Locations

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Retina Center of Texas

Southlake, Texas, United States

Site Status RECRUITING

Retina Macula Institute of AZ

Scottsdale, Arizona, United States

Site Status RECRUITING

The Retina Partners

Encino, California, United States

Site Status RECRUITING

Retinal Consultants Medical Group

Sacramento, California, United States

Site Status RECRUITING

Retina Consultants San Diego

San Diego, California, United States

Site Status RECRUITING

Star Retina

Burleson, Texas, United States

Site Status RECRUITING

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, United States

Site Status RECRUITING

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, Australia

Site Status ACTIVE_NOT_RECRUITING

Cerulea Clinical Trials

East Melbourne, Victoria, Australia

Site Status ACTIVE_NOT_RECRUITING

Rambam Medical Center

Haifa, , Israel

Site Status RECRUITING

Tel-Aviv Sourasky Medical Center, Ophthalmology Division

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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United States Australia Israel

Central Contacts

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Anne Fung, MD

Role: CONTACT

(800) 867-7960

Other Identifiers

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PBI-AMD-002

Identifier Type: -

Identifier Source: org_study_id

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