Wet Age-related Macular Degeneration (wAMD)
Conditions
Brief summary
This Phase II study is designed to evaluate the efficacy and safety of AL-001 ophthalmic injection in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will be randomized in Cohorts 1 and 2 to receive AL-001 administered via suprachoroidal space injection, Cohort 3 to receive Aflibercept.
Interventions
DRUGAL-001
Administered via suprachoroidal space injection.
DRUGAflibercept
Intravitreal injection
Sponsors
Beijing Anlong Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age≥ 50 and ≤ 85. 2. The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD. 3. The study eye has response to anti-VEGF injections. 4. The subject or their legal representative agrees to participate in this study and signs a written ICF.
Exclusion criteria
1. Non-wAMD induced CNV or macular edema in the study eye. 2. Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye. 3. Uncontrolled glaucoma in the study eye. 4. History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye. 5. Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye. 6. Ametropia (high myopia or high hyperopia) \> 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye. 7. Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma. 8. None of intraocular inflammation in the study eye. 9. Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of AL-001 on BCVA | Week 24 | Change in BCVA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Week 56 | Incidence of adverse events (AEs) and serious adverse events (SAEs) |
| Evaluate the effect of AL-001 on central retinal thickness (CRT) | Week 56 | Mean change from baseline in CRT as measured |
Countries
China
Contacts
Primary ContactAnlong Bio
Outcome results
None listed