The Phase 1 safety study of VOY-101 comprises of escalating dose Cohorts, followed by a Phase 2a.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
VOY-101
Retina Macula Institute of AZ
Scottsdale, Arizona, United States
RECRUITINGThe Retina Partners
Encino, California, United States
RECRUITINGOverall effect of treatment on retinal structural health
GA growth rate and Change in Ellipsoid Zone Integrity
Time frame: Week 48
Overall effect of treatment on retinal structural health
GA Growth Rate and Change in Ellipsoid Zone Integrity
Time frame: Weeks 36, 48, and 96
Effect of treatment on vision function
Change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCDVA and LLVA and microperimetry.
Time frame: Change from baseline
Incidence of neovascular AMD
Incidence, frequency, severity, and timing of development of neovascular AMD
Time frame: Baseline to Week 96
VOY-101 Safety
Frequency of related ocular and systemic AEs (SAEs and non-serious), adverse events of special interest (AESI) and non-serious TEAEs).
Time frame: Baseline to Week 96
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Retinal Consultants Medical Group
Sacramento, California, United States
RECRUITINGRetina Consultants San Diego
San Diego, California, United States
RECRUITINGStar Retina
Burleson, Texas, United States
RECRUITINGRetina Center of Texas
Southlake, Texas, United States
RECRUITINGUniversity of Utah John A. Moran Eye Center
Salt Lake City, Utah, United States
RECRUITINGSydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia
ACTIVE_NOT_RECRUITINGCerulea Clinical Trials
East Melbourne, Victoria, Australia
ACTIVE_NOT_RECRUITINGRambam Medical Center
Haifa, Israel
RECRUITING...and 1 more locations