Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD) (NOVA-1)
Neovascular Age-related Macular Degeneration (nAMD)
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration (nAMD) focused on measuring nAMD, retina, eyes, ophthalmology
Eligibility 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 34 letters (approximately 20/200 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 initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) in the study eye within 9 months before Screening. 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 within 28-days before Week -1 [Stage 1] or Baseline [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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Active Comparator
Cohort 1 (Stage 1)
Cohort 2 (Stage 1)
AR-14034 SR lower dose (Stage 2)
AR-14034 SR higher dose (Stage 2)
Aflibercept (Stage 2)
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.
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.
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.
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.
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.