Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)
NOVA-1
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
1 other identifier
interventional
140
1 country
42
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2023
Longer than P75 for phase_1
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2023
CompletedFirst Posted
Study publicly available on registry
March 15, 2023
CompletedStudy Start
First participant enrolled
December 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
January 6, 2026
January 1, 2026
3.8 years
March 3, 2023
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in ETDRS BCVA at the average across two visits, Weeks 44 and 48 (Stage 2)
Visual acuity will be measured after manifest refraction using Early Treatment of Diabetic Retinopathy Study (ETDRS) letter charts in a 4-meter lane under standard illumination. Best corrected visual acuity (BCVA) will be recorded as the number of letters read correctly. The difference between the average across Weeks 44 and 48, and the baseline visit will be reported. One eye (study eye) will contribute to the analysis.
Baseline, Week 44, Week 48
Secondary Outcomes (2)
Mean change from baseline in ETDRS BCVA by visit (Stage 2)
Baseline to Week 56
Mean change from baseline in Central Subfield Thickness (CST) by visit (Stage 2)
Baseline to Week 56
Study Arms (5)
Cohort 1 (Stage 1)
EXPERIMENTALOne 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.
Cohort 2 (Stage 1)
EXPERIMENTALOne 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 one injection (Stage 2)
EXPERIMENTALOne 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 two injections (Stage 2)
EXPERIMENTALOne 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.
Aflibercept (Stage 2)
ACTIVE COMPARATOROne 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.
Interventions
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
AR-14034 SR administered as an intravitreal implant
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (42)
Trinity Research Group
Dothan, Alabama, 36301, United States
Associated Retina Consultants - Gilbert
Gilbert, Arizona, 85297, United States
Associated Retina Consultants - Phoenix
Phoenix, Arizona, 85020, United States
Retina Associates of SW PC
Tucson, Arizona, 85704, United States
The Retina Partners
Encino, California, 91436, United States
Retina Associates of Orange County
Laguna Hills, California, 92653, United States
Northern California Retina Vitreous Associates Medical Group
Mountain View, California, 94040, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
Azul Vision Pasadena
Pasadena, California, 99107, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80809, United States
Retina Group of New England | Waterford
Waterford, Connecticut, 06385, United States
Florida Retina Institute
Jacksonville, Florida, 32216, United States
Mid Florida Eye Center
Mt. Dora, Florida, 32757, United States
Florida Retina Institute
Orlando, Florida, 32806, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Eye Associates of Pinellas
Pinellas Park, Florida, 33782, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Thomas Eye Group Main Office
Sandy Springs, Georgia, 30328, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452, United States
Twin Cities Eye Consultants
Coon Rapids, Minnesota, 55433, United States
Mississippi Retina Associates
Madison, Mississippi, 39110, United States
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
NYC Retina - Queens
Forest Hills, New York, 11375, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Verum Research, LLC
Eugene, Oregon, 97401, United States
Erie Retina Research
Erie, Pennsylvania, 16507, United States
MidAtlantic Retina Research
Philadelphia, Pennsylvania, 19107, United States
Retina Consultants of Carolina
Greenville, South Carolina, 29605, United States
Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, 29464, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Texas Retina Associates - Arlington
Arlington, Texas, 76012, United States
Austin Research Center for Retina
Austin, Texas, 78705, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Austin Clinical Research, LLC
Austin, Texas, 78750, United States
Star Vision Research
Burleson, Texas, 76028, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Berkeley Eye Center
Houston, Texas, 77027, United States
Retina Consultants of Texas - San Antonio
San Antonio, Texas, 78251, United States
Austin Retina Associates (San Marcos)
San Marcos, Texas, 78666, United States
Retina Research Center of Southern Utah
St. George, Utah, 84790, United States
Pacific Northwest Retina
Burlington, Washington, 98233, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Director of Clinical Development, Alcon
Alcon Research, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Stage 1 is open label. Stage 2 is double-masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2023
First Posted
March 15, 2023
Study Start
December 6, 2023
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
January 6, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share