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

• Status: Not yet recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aerie Pharmaceuticals
• Collaborator: Alcon Research
• Treatments: Aflibercept

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 9 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 within 28-days before Week -1 [Stage 1] or Baseline [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.