Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Part of paid clinical trials in Dothan, Alabama.
- Sponsor
- Alcon Research
- Study ID
- NCT05769153
- Phase
- PHASE1/PHASE2
- Status
- Active Not Recruiting
Conditions
- Neovascular Age-related Macular Degeneration (nAMD)
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AR-14034 SR implant lower dose — DRUGAR-14034 SR administered as an intravitreal implant
- AR-14034 SR implant higher dose — DRUGAR-14034 SR administered as an intravitreal implant
- AR-14034 SR implant — DRUGAR-14034 SR administered as an intravitreal implant
- Aflibercept Injection — DRUGAflibercept administered as a 2 milligram (mg) intravitreal injection
- Sham procedure — DRUGNeedleless syringe used to simulate an intravitreal injection
Study Details
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).
Key Dates
- Start date
- Dec 6, 2023
- Status verified
- May 2026
- Primary completion
- May 31, 2027
- Completion
- Oct 31, 2027
Study Design
- Enrollment
- 139 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1 (Stage 1)One intravitreal (IVT) injection of aflibercept 2 mg at Week -1 and one IVT insertion of AR-14034 SR lower dose at Baseline. Up to one retreatment with AR-14034 SR will be administered between Weeks 4 and 36 according to protocol-specified disease activity criteria.
- Experimental: Cohort 2 (Stage 1)One IVT injection of aflibercept 2 mg at Week -1 and one IVT insertion of AR-14034 SR higher dose at Baseline. Up to one retreatment with AR-14034 SR will be administered between Weeks 4 and 36 according to protocol-specified disease activity criteria.
- Experimental: AR-14034 SR one injection (Stage 2)One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR at Week 2. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections.
- Experimental: AR-14034 SR two injections (Stage 2)One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with IVT insertions of AR-14034 SR at Week 2 and Week 6. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections.
- Active Comparator: Aflibercept (Stage 2)One IVT injection of aflibercept 2 mg at Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections.
Primary Outcome Measure
Mean change from baseline in ETDRS BCVA at the average across two visits, Weeks 44 and 48 (Stage 2) [ Time Frame: Baseline, Week 44, Week 48 ]
Locations (42)
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