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.
Eligibility
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Phase 1: To evaluate the safety and tolerability of a single intravitreal injection of escalating doses of VOY-101 — 24 Months Frequency and type of ocular and systemic adverse events and non-serious treatment-emergent adverse events
Phase 1: Change from Baseline in markers of inflammation — Baseline to Month 24 Change from Baseline in markers of inflammation including anterior chamber cells, vitreous cells, and retinal vasculitis and retinitis.
Phase 1: Establish the recommended Phase 2 dose in subjects with Geographic Atrophy. — Month 12 Determine whether the maximum tolerated dose (MTD) has been reached (as determined by the occurrence of dose-limiting toxicities \[DLTs\]) and select the RP2D.
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. — 15 Months Change from Baseline in Geographic Atrophy lesion size
Trial sites (16)
Facility
City
Region
Status
Retina Macula Institute of AZ
Scottsdale
Arizona
Retina Consultants San Diego
Poway
California
Retinal Consultants Medical Group
Sacramento
California
Ophthalmic Consultants of Boston
Boston
Massachusetts
The Retina Institute
St Louis
Missouri
Mid Atlantic Retina
Cherry Hill
New Jersey
Retina Northwest
Portland
Oregon
Black Hills Regional Eye Institute
Rapid City
South Dakota
Austin Research Center for Retina
Austin
Texas
Star Retina
Fort Worth
Texas
Retina Center of Texas
Southlake
Texas
University of Utah John A. Moran Eye Center
Salt Lake City
Utah
Sydney Retina Clinic and Day Surgery
Sydney
New South Wales
Cerulea Clinical Trials
East Melbourne
Victoria
Rambam Medical Center
Haifa
Israel
Tel-Aviv Sourasky Medical Center, Ophthalmology Division
Tel Aviv
Israel
More Perceive Biotherapeutics, Inc. trials in Israel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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