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RecruitingPhase 1, Phase 2NCT05769153

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

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Trial Parameters

ConditionNeovascular Age-related Macular Degeneration (nAMD)
SponsorAlcon Research
Study TypeINTERVENTIONAL
PhasePhase 1, Phase 2
Enrollment140
SexALL
Min Age50 Years
Max AgeN/A
Start Date2023-12-06
Completion2027-10
Interventions
AR-14034 SR implant lower doseAR-14034 SR implant higher doseAR-14034 SR implant

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Brief 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).

Eligibility Criteria

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 in the informed consent form (ICF) and in this protocol; * Other protocol-specified inclusion criteria may apply. \[Stage 1\]: * Greater than or equal to 3 and less than or equal to 6 prior treatments of an ocular anti-VEGF medication within the 8 months prior to Screening in the study eye, with demonstrated anatomic response, as assessed by the Investigator. \[Stage 2\]: * Treatment-naïve, or diag

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