Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)
- Conditions
- Neovascular Age-related Macular Degeneration (nAMD)
- Interventions
- Drug: AR-14034 SR implant lower doseDrug: AR-14034 SR implant higher doseDrug: Sham procedure
- Registration Number
- NCT05769153
- Lead Sponsor
- Alcon Research
- 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 (Stage 1) Aflibercept Injection 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. Aflibercept (Stage 2) Aflibercept Injection 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 Weeks 16 and 52. Cohort 2 (Stage 1) AR-14034 SR implant higher dose 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. Cohort 1 (Stage 1) AR-14034 SR implant lower dose 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. Cohort 1 (Stage 1) Aflibercept Injection 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. Aflibercept (Stage 2) Sham procedure 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 Weeks 16 and 52. AR-14034 SR lower dose (Stage 2) AR-14034 SR implant lower dose One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR lower dose at Week 6. Up to one retreatment of AR-14034 SR will be administered between Weeks 16 and 52 according to protocol-specified disease activity criteria. Sham procedures will be performed between Weeks 16 and 52 except when AR-14034 SR repeat treatment is administered. AR-14034 SR higher dose (Stage 2) Sham procedure One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR higher dose at Week 6. Up to one retreatment of AR-14034 SR will be administered between Weeks 16 and 52 according to protocol-specified disease activity criteria. Sham procedures will be performed between Weeks 16 and 52 except when AR-14034 SR repeat treatment is administered. AR-14034 SR higher dose (Stage 2) AR-14034 SR implant higher dose One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR higher dose at Week 6. Up to one retreatment of AR-14034 SR will be administered between Weeks 16 and 52 according to protocol-specified disease activity criteria. Sham procedures will be performed between Weeks 16 and 52 except when AR-14034 SR repeat treatment is administered. AR-14034 SR lower dose (Stage 2) Aflibercept Injection One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR lower dose at Week 6. Up to one retreatment of AR-14034 SR will be administered between Weeks 16 and 52 according to protocol-specified disease activity criteria. Sham procedures will be performed between Weeks 16 and 52 except when AR-14034 SR repeat treatment is administered. AR-14034 SR lower dose (Stage 2) Sham procedure One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR lower dose at Week 6. Up to one retreatment of AR-14034 SR will be administered between Weeks 16 and 52 according to protocol-specified disease activity criteria. Sham procedures will be performed between Weeks 16 and 52 except when AR-14034 SR repeat treatment is administered. AR-14034 SR higher dose (Stage 2) Aflibercept Injection One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR higher dose at Week 6. Up to one retreatment of AR-14034 SR will be administered between Weeks 16 and 52 according to protocol-specified disease activity criteria. Sham procedures will be performed between Weeks 16 and 52 except when AR-14034 SR repeat treatment is administered.
- Primary Outcome Measures
Name Time Method Mean change from baseline in ETDRS BCVA at the average across two visits, Weeks 44 and 48 (Stage 2) Baseline, Week 44, Week 48 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.
- Secondary Outcome Measures
Name Time Method Mean change from baseline in ETDRS BCVA by visit (Stage 2) Baseline to Week 56 Visual acuity will be measured after manifest refraction using ETDRS letter charts in a 4-meter lane under standard illumination. BCVA will be recorded as the number of letters read correctly. The difference between a given post-baseline visit and the baseline visit will be reported. One eye (study eye) will contribute to the analysis.
Mean change from baseline in Central Subfield Thickness (CST) by visit (Stage 2) Baseline to Week 56 Central subfield thickness (CST) will be assessed using spectral domain optical coherence tomography (SD-OCT) imaging and measured in micrometers. The difference between a given post-baseline visit and the baseline visit will be reported. One eye (study eye) will contribute to the analysis.
Trial Locations
- Locations (29)
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
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
Retina Associates of Orange County
🇺🇸Laguna Hills, California, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Northern California Retina Vitreous Associates Medical Group
🇺🇸Mountain View, California, United States
Retinal Consultants Medical Group, Inc.
🇺🇸Sacramento, California, United States
Retina Consultants of Southern Colorado
🇺🇸Colorado Springs, Colorado, United States
Florida Retina Institute
🇺🇸Orlando, Florida, United States
Blue Ocean Clinical Research Center
🇺🇸Clearwater, Florida, United States
Eye Associates of Pinellas
🇺🇸Pinellas Park, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Thomas Eye Group
🇺🇸Sandy Springs, Georgia, United States
University Retina and Macula Associates, PC
🇺🇸Oak Forest, Illinois, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Cumberland Valley Retina Consultants, PC
🇺🇸Hagerstown, Maryland, United States
Verum Research, LLC
🇺🇸Eugene, Oregon, United States
Erie Retina Research
🇺🇸Erie, Pennsylvania, United States
Twin Cities Eye Consultants
🇺🇸Coon Rapids, Minnesota, United States
MidAtlantic Retina Research
🇺🇸Philadelphia, Pennsylvania, United States
Retina Consultants of Carolina
🇺🇸Greenville, South Carolina, United States
Carolina Eyecare Physicians LLC
🇺🇸Mount Pleasant, South Carolina, United States
Austin Research Center for Retina
🇺🇸Austin, Texas, United States
Austin Clinical Research, LLC
🇺🇸Austin, Texas, United States
Retina Consultants of Texas - San Antonio
🇺🇸San Antonio, Texas, United States
Emanuelli Research and Development Center, LLC
🇵🇷Arecibo, Puerto Rico