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Active Not Recruiting NCT05769153

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

Conditions: Neovascular Age-related Macular Degeneration (nAMD)

Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 139
Sponsor: Alcon Research

Location: Trinity Research Group Dothan Alabama

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 diagnosis of exudative neovascular age-related macular degeneration (nAMD) in the study eye. Key Exclusion Criteria \[Stage 1 and Stage 2\]: * History or current ocular disease in the study eye other than nAMD, that, might require medical or surgical intervention during the study; * Structural damage to the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the nAMD; * Any active intraocular or periocular infection or active intraocular inflammation; * Treatment with ocular anti-VEGF product in the study eye within 28 days before Week 1 \[Stage 1\] or within 56 days before Screening \[Stage 2\]. * Uncontrolled glaucoma in the study eye; * Uncontrolled blood pressure; * Females of child-bearing potential who are pregnant, intending to become pregnant, nursing, or who are not willing to use an acceptable form of contraception for the duration of the study; * Other protocol-specified exclusion criteria may apply.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05769153). StuddyBuddy aggregates publicly available trial information.