Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Purpose
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).
Condition
- Neovascular Age-related Macular Degeneration (nAMD)
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 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.
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 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; - Other protocol-specified exclusion criteria may apply.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Stage 1 will enroll 2 cohorts. Stage 2 will enroll 3 treatment arms.
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Stage 1 is open label. Stage 2 is double-masked.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Dothan, Alabama 36301
Gilbert, Arizona 85297
Phoenix, Arizona 85020
Tucson, Arizona 85704
Laguna Hills, California 92653
Mountain View, California 94040
Colorado Springs, Colorado 80809
Waterford, Connecticut 06385
Orlando, Florida 32806
Pensacola, Florida 32503
Pinellas Park, Florida 33782
Winter Haven, Florida 33880
Sandy Springs, Georgia 30328
Oak Forest, Illinois 60452
Coon Rapids, Minnesota 55433
Madison, Mississippi 39110
Forest Hills, New York 11375
Eugene, Oregon 97401
Erie, Pennsylvania 16507
Philadelphia, Pennsylvania 19107
Greenville, South Carolina 29605
Mt. Pleasant, South Carolina 29464
Abilene, Texas 79606
Austin, Texas 78705
Austin, Texas 78705
Austin, Texas 78750
Dallas, Texas 75231
Burlington, Washington 98233
More Details
- NCT ID
- NCT05769153
- Status
- Recruiting
- Sponsor
- Alcon Research
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 will receive AR-14034 SR in one of two dose levels and 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 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.