First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME)
This is a first-in-human study conducted in 2 sequential stages; each stage is 24 weeks in duration. Subjects with nAMD and subjects with DME were evaluated in Stage 1. Subjects with DME will be evaluated in Stage 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye
AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye
AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye
Retinal Research Institute, LLC
Gilbert, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Sterling Vision, PC dba Oregon Retina
Eugene, Oregon, United States
Number of ocular and non-ocular TEAEs
Number of ocular and non-ocular treatment-emergent adverse events (TEAEs), summarized at the subject level by system organ class and preferred term, and also by severity and relatedness to treatment.
Time frame: 24 weeks
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AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye
Valley Retina Institute, P.A.
Harlingen, Texas, United States
Medical Center Ophthamology Associates
San Antonio, Texas, United States