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Evaluating AR-14034 for treating neovascular age-related macular degeneration

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

Phase1; Phase2 Interventional Alcon Research · NCT05769153

This study is testing a new treatment called AR-14034 for people with neovascular age-related macular degeneration to see if it is safe and works better than the current standard treatment.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment140 (estimated)
Ages50 Years and up
SexAll
SponsorAlcon Research Industry-sponsored
Locations42 sites (Dothan, Alabama and 41 other locations)
Trial IDNCT05769153 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of AR-14034 Sustained Release (SR) in patients with neovascular age-related macular degeneration (nAMD). The study consists of two stages: the first stage is a 48-week open-label evaluation with a small group of participants to determine safety and preliminary treatment effects. The second stage is a 56-week randomized, double-masked comparison of AR-14034 SR against aflibercept, involving a larger cohort to further evaluate safety and treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals with active choroidal neovascularization lesions due to age-related macular degeneration and specific visual acuity criteria.

Not a fit: Patients who have not previously received anti-VEGF treatments or those with certain ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from nAMD, potentially improving their vision and quality of life.

How similar studies have performed: Previous studies have shown promise with similar approaches in treating nAMD, but the specific use of AR-14034 SR is novel.

Eligibility criteria

Show full inclusion / exclusion 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 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 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;
* Other protocol-specified exclusion criteria may apply.

Where this trial is running

Dothan, Alabama and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neovascular Age-related Macular DegenerationnAMDretinaeyesophthalmology
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.