Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)
NCT ID: NCT05769153
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
140 participants
INTERVENTIONAL
2023-12-06
2027-10-31
Brief Summary
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Detailed Description
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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 one injection, AR-14034 SR two injections, 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1 (Stage 1)
One intravitreal (IVT) injection of aflibercept 2 mg at Week -1 and one IVT insertion of AR-14034 SR lower dose at Baseline. Up to one retreatment with AR-14034 SR will be administered between Weeks 4 and 36 according to protocol-specified disease activity criteria.
AR-14034 SR implant lower dose
AR-14034 SR administered as an intravitreal implant
Aflibercept Injection
Aflibercept administered as a 2 milligram (mg) intravitreal injection
Cohort 2 (Stage 1)
One IVT injection of aflibercept 2 mg at Week -1 and one IVT insertion of AR-14034 SR higher dose at Baseline. Up to one retreatment with AR-14034 SR will be administered between Weeks 4 and 36 according to protocol-specified disease activity criteria.
AR-14034 SR implant higher dose
AR-14034 SR administered as an intravitreal implant
Aflibercept Injection
Aflibercept administered as a 2 milligram (mg) intravitreal injection
AR-14034 SR one injection (Stage 2)
One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR at Week 2. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections.
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
AR-14034 SR two injections (Stage 2)
One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with IVT insertions of AR-14034 SR at Week 2 and Week 6. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections.
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
Aflibercept (Stage 2)
One IVT injection of aflibercept 2 mg at Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections.
Aflibercept Injection
Aflibercept administered as a 2 milligram (mg) intravitreal injection
Sham procedure
Needleless syringe used to simulate an intravitreal injection
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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;
50 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Director of Clinical Development, Alcon
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Trinity Research Group
Dothan, Alabama, United States
Associated Retina Consultants - Gilbert
Gilbert, Arizona, United States
Associated Retina Consultants - Phoenix
Phoenix, Arizona, United States
Retina Associates of SW PC
Tucson, Arizona, United States
The Retina Partners
Encino, California, United States
Retina Associates of Orange County
Laguna Hills, California, United States
Northern California Retina Vitreous Associates Medical Group
Mountain View, California, United States
Eye Research Foundation
Newport Beach, California, United States
Azul Vision Pasadena
Pasadena, California, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
Retina Group of New England | Waterford
Waterford, Connecticut, United States
Florida Retina Institute
Jacksonville, Florida, United States
Mid Florida Eye Center
Mt. Dora, Florida, United States
Florida Retina Institute
Orlando, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Eye Associates of Pinellas
Pinellas Park, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Thomas Eye Group Main Office
Sandy Springs, Georgia, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Twin Cities Eye Consultants
Coon Rapids, Minnesota, United States
Mississippi Retina Associates
Madison, Mississippi, United States
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, United States
NYC Retina - Queens
Forest Hills, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Verum Research, LLC
Eugene, Oregon, United States
Erie Retina Research
Erie, Pennsylvania, United States
MidAtlantic Retina Research
Philadelphia, Pennsylvania, United States
Retina Consultants of Carolina
Greenville, South Carolina, United States
Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates - Arlington
Arlington, Texas, United States
Austin Research Center for Retina
Austin, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Star Vision Research
Burleson, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Berkeley Eye Center
Houston, Texas, United States
Retina Consultants of Texas - San Antonio
San Antonio, Texas, United States
Austin Retina Associates (San Marcos)
San Marcos, Texas, United States
Retina Research Center of Southern Utah
St. George, Utah, United States
Pacific Northwest Retina
Burlington, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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RTE888-E001
Identifier Type: -
Identifier Source: org_study_id
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