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

NCT06087458 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PBI-AMD-002
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 16

Brief 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.

Conditions

Age-Related Macular Degeneration; Geographic Atrophy; Non-neovascular AMD; Non-neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (4)

• Phase 1: To evaluate the safety and tolerability of a single intravitreal injection of escalating doses of VOY-101

  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

  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.

  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.

  Change from Baseline in Geographic Atrophy lesion size

  15 Months

Secondary Outcomes (7)

• Phase 1: To evaluate the effect of VOY-101 on geographic atrophy lesion size and photoreceptors

  Baseline through 24 Months

• Phase 1/2: To establish the pharmacokinetic (PK) profile of VOY-101.

  Baseline through 24 Months

• Phase 1/2: To evaluate the effect of VOY-101 on best corrected distance visual acuity

  24 Months

• Phase 1/2: Development of macular neovascularization

  Month 24

• Phase 2: To further characterize the ocular and systemic safety and tolerability of VOY-101

  24 Months

Study Arms (5)

Low

EXPERIMENTAL

Single, unilateral, intravitreal injection of low dose of VOY-101

Biological: VOY-101

Medium

EXPERIMENTAL

Single, unilateral, intravitreal injection of medium dose of VOY-101

Biological: VOY-101

High

EXPERIMENTAL

Single, unilateral, intravitreal injection of high dose of VOY-101

Biological: VOY-101

Higher

EXPERIMENTAL

Single, unilateral, intravitreal injection of higher dose of VOY-101

Biological: VOY-101

Intermediate

EXPERIMENTAL

Single, unilateral, intravitreal injection of intermediate dose of VOY-101

Biological: VOY-101

Interventions

VOY-101 BIOLOGICAL

VOY-101

High; Higher; Intermediate; Low; Medium

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Perceive Biotherapeutics, Inc.: lead

Study Sites (16)

Retina Macula Institute of AZ

Scottsdale, Arizona, 85255, United States

Location

Retina Consultants San Diego

Poway, California, 92064, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95825, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

The Retina Institute

St Louis, Missouri, 63128, United States

Location

Mid Atlantic Retina

Cherry Hill, New Jersey, 08034, United States

Location

Retina Northwest

Portland, Oregon, 97221, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Austin Research Center for Retina

Austin, Texas, 78705, United States

Location

Star Retina

Fort Worth, Texas, 76132, United States

Location

Retina Center of Texas

Southlake, Texas, 76092, United States

Location

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, 2000, Australia

Location

Cerulea Clinical Trials

East Melbourne, Victoria, 3002, Australia

Location

Rambam Medical Center

Haifa, Israel

Location

Tel-Aviv Sourasky Medical Center, Ophthalmology Division

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Macular Degeneration; Geographic Atrophy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Anne Fung, MD

  Perceive Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Central Reading Center is masked.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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.

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 17, 2023
• Study Start: June 21, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); US (12); IL (2)