Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD) (NCT05769153) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)
United States139 participantsStarted 2023-12-06
Plain-language 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).
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 inflamm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change from baseline in ETDRS BCVA at the average across two visits, Weeks 44 and 48 (Stage 2)