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
Status: Recruiting
Location: See all (42) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Trinity Research Group
RECRUITING
Dothan
Arizona
Associated Retina Consultants - Gilbert
RECRUITING
Gilbert
Associated Retina Consultants - Phoenix
RECRUITING
Phoenix
Retina Associates of SW PC
RECRUITING
Tucson
California
The Retina Partners
NOT_YET_RECRUITING
Encino
Retina Associates of Orange County
RECRUITING
Laguna Hills
Northern California Retina Vitreous Associates Medical Group
RECRUITING
Mountain View
Eye Research Foundation
NOT_YET_RECRUITING
Newport Beach
Azul Vision Pasadena
NOT_YET_RECRUITING
Pasadena
Colorado
Retina Consultants of Southern Colorado
RECRUITING
Colorado Springs
Connecticut
Retina Group of New England | Waterford
RECRUITING
Waterford
Florida
Florida Retina Institute
NOT_YET_RECRUITING
Jacksonville
Mid Florida Eye Center
NOT_YET_RECRUITING
Mt. Dora
Florida Retina Institute
RECRUITING
Orlando
Retina Specialty Institute
RECRUITING
Pensacola
Eye Associates of Pinellas
RECRUITING
Pinellas Park
Center for Retina and Macular Disease
RECRUITING
Winter Haven
Georgia
Southeast Retina Center
NOT_YET_RECRUITING
Augusta
Thomas Eye Group Main Office
RECRUITING
Sandy Springs
Illinois
University Retina and Macula Associates, PC
RECRUITING
Oak Forest
Minnesota
Twin Cities Eye Consultants
RECRUITING
Coon Rapids
Mississippi
Mississippi Retina Associates
RECRUITING
Madison
New Mexico
Vision Research Center Eye Associates of New Mexico
NOT_YET_RECRUITING
Albuquerque
New York
NYC Retina - Queens
RECRUITING
Forest Hills
Ohio
University Hospitals Cleveland Medical Center
NOT_YET_RECRUITING
Cleveland
Oregon
Verum Research, LLC
RECRUITING
Eugene
Pennsylvania
Erie Retina Research
RECRUITING
Erie
MidAtlantic Retina Research
RECRUITING
Philadelphia
South Carolina
Retina Consultants of Carolina
RECRUITING
Greenville
Carolina Eyecare Physicians LLC
RECRUITING
Mt. Pleasant
Texas
Retina Research Institute of Texas
RECRUITING
Abilene
Texas Retina Associates - Arlington
NOT_YET_RECRUITING
Arlington
Austin Clinical Research, LLC
RECRUITING
Austin
Austin Research Center for Retina
RECRUITING
Austin
Austin Retina Associates
RECRUITING
Austin
Star Vision Research
NOT_YET_RECRUITING
Burleson
Texas Retina Associates
RECRUITING
Dallas
Berkeley Eye Center
NOT_YET_RECRUITING
Houston
Retina Consultants of Texas - San Antonio
NOT_YET_RECRUITING
San Antonio
Austin Retina Associates (San Marcos)
NOT_YET_RECRUITING
San Marcos
Utah
Retina Research Center of Southern Utah
NOT_YET_RECRUITING
St. George
Washington
Pacific Northwest Retina
RECRUITING
Burlington
Contact Information
Primary
Alcon Call Center
alcon.medinfo@alcon.com
1-888-451-3937
Time Frame
Start Date:2023-12-06
Estimated Completion Date:2027-09
Participants
Target number of participants:140
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Active_comparator: 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.