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

Last updated: April 9, 2025
Sponsor: Alcon Research
Overall Status: Active - Recruiting

Phase

1/2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

AR-14034 SR implant higher dose

Sham procedure

AR-14034 SR implant lower dose

Clinical Study ID

NCT05769153
RTE888-E001
  • Ages > 50
  • All Genders

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 Criteria

Inclusion

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 34 letters (approximately 20/200 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 initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) in the study eye within 9 months before Screening.

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 within 28-days before Week -1 [Stage 1] or Baseline [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.

Study Design

Total Participants: 140
Treatment Group(s): 4
Primary Treatment: AR-14034 SR implant higher dose
Phase: 1/2
Study Start date:
December 06, 2023
Estimated Completion Date:
April 30, 2027

Study Description

This study will be conducted in two stages. Stage 1 is a 48-week, dose-escalation, open-label evaluation of AR-14034 SR. Two cohorts will be enrolled, for an approximate total of 10 subjects. Subjects in both cohorts will attend visits through Week 48 for assessment of safety and preliminary treatment effects.

Stage 2 is a 56-week (plus extension) double-masked, active comparator, randomized, parallel group evaluation of AR-14034 SR compared with aflibercept. Approximately 130 subjects will be enrolled and randomized 2:2:1 to AR-14034 SR lower dose, AR-14034 SR higher dose, or aflibercept dosed as labelled. Subjects will attend visits through Week 56 for assessment of safety and treatment effects. A 16-week open label extension phase will be conducted thereafter.

Connect with a study center

  • Emanuelli Research and Development Center, LLC

    Arecibo, 00612
    Puerto Rico

    Active - Recruiting

  • Trinity Research Group

    Dothan, Alabama 36301
    United States

    Active - Recruiting

  • Associated Retina Consultants - Gilbert

    Gilbert, Arizona 85297
    United States

    Active - Recruiting

  • Associated Retina Consultants - Phoenix

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Retina Associates of SW PC

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • Retina Associates of Orange County

    Laguna Hills, California 92653
    United States

    Active - Recruiting

  • Northern California Retina Vitreous Associates Medical Group

    Mountain View, California 94040
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California 95825
    United States

    Active - Recruiting

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado 80809
    United States

    Active - Recruiting

  • Blue Ocean Clinical Research Center

    Clearwater, Florida 33761
    United States

    Active - Recruiting

  • Florida Retina Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Retina Specialty Institute

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Eye Associates of Pinellas

    Pinellas Park, Florida 33782
    United States

    Active - Recruiting

  • Retina Vitreous Associates of Florida

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Center for Retina and Macular Disease

    Winter Haven, Florida 33880
    United States

    Active - Recruiting

  • Thomas Eye Group

    Sandy Springs, Georgia 30328
    United States

    Active - Recruiting

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois 60452
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants, PC

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Twin Cities Eye Consultants

    Coon Rapids, Minnesota 55433
    United States

    Active - Recruiting

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Verum Research, LLC

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Erie Retina Research

    Erie, Pennsylvania 16507
    United States

    Active - Recruiting

  • MidAtlantic Retina Research

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Retina Consultants of Carolina

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Carolina Eyecare Physicians LLC

    Mount Pleasant, South Carolina 29464
    United States

    Active - Recruiting

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Texas Retina Associates

    Arlington, Texas 76102
    United States

    Active - Recruiting

  • Austin Clinical Research, LLC

    Austin, Texas 78750
    United States

    Active - Recruiting

  • Austin Research Center for Retina

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Medical Center Ophthalmology Associates

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Consultants of Texas - San Antonio

    San Antonio, Texas 78251
    United States

    Active - Recruiting

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