The primary purpose of this study is to evaluate the safety and durability of single- and repeat administration of AR-14034 Sustained Release (SR) in subjects with neovascular age-related macular degeneration (nAMD).
This study will be conducted in two stages. Stage 1 is a 48-week, dose-escalation, open-label evaluation of AR-14034 SR. Two cohorts will be enrolled, for an approximate total of 10 subjects. Subjects will receive AR-14034 SR in one of two dose levels and attend visits through Week 48 for assessment of safety and preliminary treatment effects. Stage 2 is a 56-week (plus extension) double-masked, active comparator, randomized, parallel group evaluation of AR-14034 SR compared with aflibercept. Approximately 130 subjects will be enrolled and randomized 2:2:1 to AR-14034 SR one injection, AR-14034 SR two injections, or aflibercept dosed as labelled. Subjects will attend visits through Week 56 for assessment of safety and treatment effects. A 16-week open label extension phase will be conducted thereafter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
AR-14034 SR administered as an intravitreal implant
AR-14034 SR administered as an intravitreal implant
AR-14034 SR administered as an intravitreal implant
Mean change from baseline in ETDRS BCVA at the average across two visits, Weeks 44 and 48 (Stage 2)
Visual acuity will be measured after manifest refraction using Early Treatment of Diabetic Retinopathy Study (ETDRS) letter charts in a 4-meter lane under standard illumination. Best corrected visual acuity (BCVA) will be recorded as the number of letters read correctly. The difference between the average across Weeks 44 and 48, and the baseline visit will be reported. One eye (study eye) will contribute to the analysis.
Time frame: Baseline, Week 44, Week 48
Mean change from baseline in ETDRS BCVA by visit (Stage 2)
Visual acuity will be measured after manifest refraction using ETDRS letter charts in a 4-meter lane under standard illumination. BCVA will be recorded as the number of letters read correctly. The difference between a given post-baseline visit and the baseline visit will be reported. One eye (study eye) will contribute to the analysis.
Time frame: Baseline to Week 56
Mean change from baseline in Central Subfield Thickness (CST) by visit (Stage 2)
Central subfield thickness (CST) will be assessed using spectral domain optical coherence tomography (SD-OCT) imaging and measured in micrometers. The difference between a given post-baseline visit and the baseline visit will be reported. One eye (study eye) will contribute to the analysis.
Time frame: Baseline to Week 56
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Aflibercept administered as a 2 milligram (mg) intravitreal injection
Needleless syringe used to simulate an intravitreal injection
Trinity Research Group
Dothan, Alabama, United States
RECRUITINGAssociated Retina Consultants - Gilbert
Gilbert, Arizona, United States
RECRUITINGAssociated Retina Consultants - Phoenix
Phoenix, Arizona, United States
RECRUITINGRetina Associates of SW PC
Tucson, Arizona, United States
RECRUITINGThe Retina Partners
Encino, California, United States
NOT_YET_RECRUITINGRetina Associates of Orange County
Laguna Hills, California, United States
RECRUITINGNorthern California Retina Vitreous Associates Medical Group
Mountain View, California, United States
RECRUITINGEye Research Foundation
Newport Beach, California, United States
NOT_YET_RECRUITINGAzul Vision Pasadena
Pasadena, California, United States
NOT_YET_RECRUITINGRetina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
RECRUITING...and 32 more locations