Medical Center Ophthalmology Associates | San Antonio, TX
Status and phase
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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).
Full description
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 in both cohorts will 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 lower dose, AR-14034 SR higher dose, 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.
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Inclusion and exclusion criteria
Key Inclusion Criteria [Stage 1 and Stage 2]:
[Stage 1]:
[Stage 2]:
Key Exclusion Criteria [Stage 1 and Stage 2]:
Primary purpose
Allocation
Interventional model
Masking
140 participants in 5 patient groups
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Central trial contact
Alcon Call Center
Data sourced from clinicaltrials.gov
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