Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD) (NCT05769153) | Clinical Trial Compass
RecruitingPhase 1/2
Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)
United States140 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 range50 Years
SexALL
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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…
What they're measuring
1
Mean change from baseline in ETDRS BCVA at the average across two visits, Weeks 44 and 48 (Stage 2)