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

Age-Related Macular Degeneration Clinical Trial

Official title:

Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non- Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087458
• Other study ID #: PBI-AMD-002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 21, 2023
• Est. completion date: October 2027

Study information

• Verified date: April 2024
• Source: Perceive Biotherapeutics, Inc.
• Contact: Anne Fung, MD
• Phone: (800) 867-7960
• Email: Voy101clinical[@]perceivebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: October 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Are =50 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.

• Absence of signs of non-exudative MNV.

• Additional Ocular Inclusion Criteria for study eye.

• 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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Biological:
• VOY-101
VOY-101

Locations

Country	Name	City	State
Australia	Cabrini Research	Melbourne	Victoria
Australia	Centre for Eye Research Australia (CERA)	Melbourne	Victoria
Australia	Sydney Retina Clinic and Day Surgery	Sydney	New South Wales
Israel	Tel-Aviv Sourasky Medical Center, Ophthalmology Division	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Perceive Biotherapeutics, Inc.

Countries where clinical trial is conducted

Australia,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoints and Tolerability	Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])	24 months