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Clinical Trials in the USA / NCT05769153
Active, not recruiting Phase 1/2

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

NCT05769153 · tracked via the Priya Life Science USA tracker
Sponsor
Alcon Research
Phase
Phase 1/2
Started
2023-12-06
Last updated
2026-08-27

Condition(s) studied

Neovascular Age-related Macular Degeneration (nAMD)

Investigational drug(s) / intervention(s)

AR-14034 SR implant lower doseAR-14034 SR implant higher doseAR-14034 SR implantAflibercept InjectionSham procedure

AR-14034 SR implant lower dose: AR-14034 SR administered as an intravitreal implant

AR-14034 SR implant higher dose: AR-14034 SR administered as an intravitreal implant

AR-14034 SR implant: AR-14034 SR administered as an intravitreal implant

Aflibercept Injection: Aflibercept administered as a 2 milligram (mg) intravitreal injection

Sham procedure: Needleless syringe used to simulate an intravitreal injection

Study 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

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
Trinity Research Group Dothan Alabama
Associated Retina Consultants - Gilbert Gilbert Arizona
Associated Retina Consultants - Phoenix Phoenix Arizona
Retina Associates of SW PC Tucson Arizona
The Retina Partners Encino California
Retina Associates of Orange County Laguna Hills California
Northern California Retina Vitreous Associates Medical Group Mountain View California
Eye Research Foundation Newport Beach California
Azul Vision Pasadena Pasadena California
Retina Consultants of Southern Colorado Colorado Springs Colorado
Retina Group of New England | Waterford Waterford Connecticut
Florida Retina Institute Jacksonville Florida
Mid Florida Eye Center Mt. Dora Florida
Florida Retina Institute Orlando Florida
Retina Specialty Institute Pensacola Florida
Eye Associates of Pinellas Pinellas Park Florida
Center for Retina and Macular Disease Winter Haven Florida
Southeast Retina Center Augusta Georgia
Thomas Eye Group Main Office Sandy Springs Georgia
University Retina and Macula Associates, PC Oak Forest Illinois
Twin Cities Eye Consultants Coon Rapids Minnesota
Mississippi Retina Associates Madison Mississippi
Vision Research Center Eye Associates of New Mexico Albuquerque New Mexico
NYC Retina - Queens Forest Hills New York
University Hospitals Cleveland Medical Center Cleveland Ohio
Verum Research, LLC Eugene Oregon
Erie Retina Research Erie Pennsylvania
MidAtlantic Retina Research Philadelphia Pennsylvania
Retina Consultants of Carolina Greenville South Carolina
Carolina Eyecare Physicians LLC Mt. Pleasant South Carolina
Retina Research Institute of Texas Abilene Texas
Texas Retina Associates - Arlington Arlington Texas
Austin Research Center for Retina Austin Texas
Austin Retina Associates Austin Texas
Austin Clinical Research, LLC Austin Texas
Star Vision Research Burleson Texas
Texas Retina Associates Dallas Texas
Berkeley Eye Center Houston Texas
Retina Consultants of Texas - San Antonio San Antonio Texas
Austin Retina Associates (San Marcos) San Marcos Texas

+ 2 more sites — see the full list on the official registry below.

More Alcon Research trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05769153 on ClinicalTrials.gov ↗ ← All trials in the USA