Evaluating VOY-101 for advanced age-related macular degeneration

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

This study is testing a new treatment called VOY-101 to see if it is safe and can help improve vision for people with advanced age-related macular degeneration.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Perceive Biotherapeutics, Inc. (industry)
• Locations: 11 sites (Scottsdale, Arizona and 10 other locations)
• Trial ID: NCT06087458 on ClinicalTrials.gov

What this trial studies

This study is a prospective, open-label, multi-center Phase 1/2a evaluation of VOY-101, focusing on its safety through escalating dose cohorts. Participants will receive a single unilateral intravitreal injection of VOY-101 to assess its effects on advanced non-neovascular age-related macular degeneration (AMD). The study aims to gather data on the safety profile of the treatment and its potential efficacy in improving vision-related outcomes for patients with this condition.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older with well-demarcated geographic atrophy secondary to AMD and no history of macular neovascularization.

Not a fit: Patients with active macular neovascularization or those who do not meet the specific genotype criteria for AMD may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from advanced age-related macular degeneration.

How similar studies have performed: While this approach is novel in its specific application, similar studies targeting AMD have shown promise in the past.

Eligibility criteria

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.

Where this trial is running

Scottsdale, Arizona and 10 other locations

• Retina Macula Institute of AZ — Scottsdale, Arizona, United States (RECRUITING)
• The Retina Partners — Encino, California, United States (RECRUITING)
• Retinal Consultants Medical Group — Sacramento, California, United States (RECRUITING)
• Retina Consultants San Diego — San Diego, California, United States (RECRUITING)
• Star Retina — Burleson, Texas, United States (RECRUITING)
• Retina Center of Texas — Southlake, Texas, United States (RECRUITING)
• University of Utah John A. Moran Eye Center — Salt Lake City, Utah, United States (RECRUITING)
• Sydney Retina Clinic and Day Surgery — Sydney, New South Wales, Australia (ACTIVE_NOT_RECRUITING)
• Cerulea Clinical Trials — East Melbourne, Victoria, Australia (ACTIVE_NOT_RECRUITING)
• Rambam Medical Center — Haifa, Israel (RECRUITING)
• Tel-Aviv Sourasky Medical Center, Ophthalmology Division — Tel Aviv, Israel (RECRUITING)

Study contacts

• Study coordinator: Anne Fung, MD

Conditions: Age-Related Macular Degeneration, Geographic Atrophy, Non-neovascular AMD