Age Related Macular Degeneration, wetAMD
Conditions
Keywords
wetAMD, CNV, eyedrop, TKI, Axitinib, Phase2
Brief summary
Trial to Evaluate the Safety and Efficacy of SCAI-005 Ophthalmic solution in Patients with Neovascular Age-related Macular Degeneration. The purpose of this study is to investigate the efficacy, safety and tolerability of SCAI-005 Ophthalmic solution by dose in patients with neovascular Age-related Macular Degeneration (nAMD).
Detailed description
Subjects who have been informed about the study and have voluntarily agreed to sign to participate in the study will be screened. Subjects who meet the inclusion/exclusion criteria will be randomized in 2:2:1 ratio into SCAI-005 0.04% and SCAI-005 0.08% and Placebo group. Efficacy will be assessed at Weeks 4, 8, and 12. Safety and tolerability will be assessed until 12 weeks after randomization.
Interventions
DRUGSCAI-005 0.04% 2drops TID
Axitinib 0.084mg/day
DRUGSCAI-005 0.08% 2drops TID
Axinitib 0.168mg/day
DRUGPlacebo 2drops TID
vehicle
Sponsors
SCAI Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 50 years or older 2. Subjects who were diagnosed with nAMD in the study eye within 3 years prior to the Screening Visit, who demonstrated a treatment response to at least 3 repeated intravitreal injections of anti-VEGF IVT for nAMD, and whose last anti-VEGF IVT administration was more than 12 weeks prior to the planned date of the first administration of the investigational product. 3. Active MNV secondary to nAMD with a subfoveal component related to the MNV activity in the study eye as assessed by FA (evidence of leakage) or SD-OCT (presence of fluid) at screening 4. CST ≤ 450 μm at screening 5. BCVA ETDRS letter score of 80 letters to 25 letters in the study eye as measured by the ETDRS visual acuity chart at screening
Exclusion criteria
1. Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled) 2. Presence of scarring, fibrosis, or atrophy involving the fovea in the study eye at Screening 3. Subjects who have a hemorrhage in the subfoveal region of the study eye and in whom the subretinal hemorrhage area is ≥ 1 optic disk area 4. History of glaucoma surgery, vitrectomy, submacular surgery, or macular laser treatment (e.g., photodynamic therapy \[PDT\], laser photocoagulation, etc.) in the study eye 5. Subjects with vitreous hemorrhage in the study eye 6. History of ocular treatment (except for anti-VEGF IVT therapy), systemic treatment, or surgical intervention for the treatment of neovascular age-related macular degeneration (nAMD) in the study eye 7. Administration of intraocular, periocular, or intravitreal (IVT) steroid injection in the study eye within 24 weeks prior to Screening 8. Presence of diabetic retinopathy, diabetic macular edema, or other vascular diseases affecting the retina, other than neovascular age-related macular degeneration (nAMD), in either eye 9. History of endophthalmitis or idiopathic or autoimmune-related uveitis in either eye 10. Subjects with active macular neovascularization identified in the fellow eye at Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Central Subfield Thickness | 12weeks | measured by SD-OCT |
Contacts
CONTACTYoujeong Heo
Outcome results
None listed