Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)
A Phase 1/2 Two-Stage Dose Escalation and Randomized Parallel-Group Study to Evaluate the Safety, Preliminary Treatment Effects, and Durability of AR-14034 Sustained Release Implant Compared to Intravitreal Anti-Vascular Endothelial Growth Factor Treatment in Participants With Neovascular Age-Related Macular Degeneration
Alcon Research
140 participants
Dec 6, 2023
INTERVENTIONAL
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).
Eligibility
Inclusion Criteria9
- 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;
- \[Stage 1\]:
- 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.
Exclusion Criteria7
- 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 56 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;
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Interventions
AR-14034 SR administered as an intravitreal implant
AR-14034 SR administered as an intravitreal implant
AR-14034 SR administered as an intravitreal implant
Aflibercept administered as a 2 milligram (mg) intravitreal injection
Needleless syringe used to simulate an intravitreal injection
Locations(42)
View Full Details on ClinicalTrials.gov
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NCT05769153