NCT05769153

Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Detailed 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-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.

Conditions

• Neovascular Age-related Macular Degeneration (nAMD)

Interventions

Type	Name	Description
DRUG	AR-14034 SR implant lower dose	AR-14034 SR administered as an intravitreal implant
DRUG	AR-14034 SR implant higher dose	AR-14034 SR administered as an intravitreal implant
DRUG	AR-14034 SR implant	AR-14034 SR administered as an intravitreal implant
DRUG	Aflibercept Injection	Aflibercept administered as a 2 milligram (mg) intravitreal injection
DRUG	Sham procedure	Needleless syringe used to simulate an intravitreal injection

Timeline

• Start date: 2023-12-06
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2023-03-15
• Last updated: 2026-01-06

Locations

42 sites across 1 country: United States

Regulatory

• FDA-regulated drug study