A Phase 1/2 Two-Stage Dose Escalation and Randomized Parallel-Group Study to Evaluate the Safety, Preliminary Treatment Effects, and Durability of AR-14034 Sustained Release Implant Compared to Intravitreal Anti-Vascular Endothelial Growth Factor Treatment in Participants With Neovascular Age-Related Macular Degeneration
Alcon Research
Summary
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).
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 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-140…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria \[Stage 1 and Stage 2\]: * Presence of an active choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD); * Best corrected visual acuity (BCVA) between 80 and 35 letters (20/25 to 20/200 Snellen equivalent) in the study eye; * BCVA greater than 20 letters (approximately 20/400 Snellen equivalent) in the non-study eye; * Media clarity and pupillary dilation in the study eye sufficient for all planned study procedures; * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed…
Interventions
- DrugAR-14034 SR implant lower dose
AR-14034 SR administered as an intravitreal implant
- DrugAR-14034 SR implant higher dose
AR-14034 SR administered as an intravitreal implant
- DrugAR-14034 SR implant
AR-14034 SR administered as an intravitreal implant
- DrugAflibercept Injection
Aflibercept administered as a 2 milligram (mg) intravitreal injection
- DrugSham procedure
Needleless syringe used to simulate an intravitreal injection
Locations (42)
- Trinity Research GroupDothan, Alabama
- Associated Retina Consultants - GilbertGilbert, Arizona
- Associated Retina Consultants - PhoenixPhoenix, Arizona
- Retina Associates of SW PCTucson, Arizona
- The Retina PartnersEncino, California
- Retina Associates of Orange CountyLaguna Hills, California