Neovascular Age-related Macular Degeneration (nAMD)
Conditions
Keywords
nAMD, retina, eyes, ophthalmology
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 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.
Interventions
DRUGAR-14034 SR implant lower dose
AR-14034 SR administered as an intravitreal implant
DRUGAR-14034 SR implant higher dose
AR-14034 SR administered as an intravitreal implant
DRUGAR-14034 SR implant
AR-14034 SR administered as an intravitreal implant
Aflibercept administered as a 2 milligram (mg) intravitreal injection
DRUGSham procedure
Needleless syringe used to simulate an intravitreal injection
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Stage 1 is open label. Stage 2 is double-masked.
Intervention model description
Stage 1 will enroll 2 cohorts. Stage 2 will enroll 3 treatment arms.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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. Key
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactAlcon Call Center
Outcome results
None listed