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

Korábbi kezelés

• 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].

Más betegség

• History or current ocular disease in the study eye other than nAMD, that, might require medical or surgical intervention during the study;
• Any active intraocular or periocular infection or active intraocular inflammation;

Egyéb

• Structural damage to the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the nAMD;
• 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.

• 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.