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

Launched by ALCON RESEARCH · Mar 3, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called AR-14034 for patients with neovascular age-related macular degeneration (nAMD), a condition that can lead to vision loss. The main goal of the study is to check how safe the treatment is and how long its effects last when given either once or multiple times. The trial is currently looking for participants, and it is open to adults aged 18 and older, regardless of gender.

To be eligible for the trial, participants should have an active eye condition caused by nAMD and a certain level of vision in both eyes. This means that the study eye should have a specific type of abnormal blood vessel growth, and the vision in the study eye must meet set criteria. Participants can expect to receive the study treatment and will be monitored closely for any side effects or improvements in their vision. It’s important to know that individuals with other serious eye diseases or uncontrolled health conditions may not qualify for this study.

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ALL

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 34 letters (approximately 20/200 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 initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) in the study eye within 12 months before Screening.
• 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 60-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.