Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AL-001, Aflibercept.
- Who it may be relevant to
- Registry conditions: Wet Age-related Macular Degeneration (wAMD). Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II, Randomized, Positive-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Single Suprachoroidal Space Injection of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)
Overview
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
- Drug AL-001
Administered via suprachoroidal space injection. - Drug Aflibercept
Intravitreal injection
Primary outcome measures
- Evaluate the effect of AL-001 on BCVA [Time frame: Week 24]
Secondary outcome measures (2)
- Safety [Time frame: Week 56]
- Evaluate the effect of AL-001 on central retinal thickness (CRT) [Time frame: Week 56]
Eligibility criteria
Inclusion criteria
- Age≥ 50 and ≤ 85.
- The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
- The study eye has response to anti-VEGF injections.
- The subject or their legal representative agrees to participate in this study and signs a written ICF.
Exclusion criteria
- Non-wAMD induced CNV or macular edema in the study eye.
- Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
- Uncontrolled glaucoma in the study eye.
- History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
- Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye.
- Ametropia (high myopia or high hyperopia) > 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye.
- Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
- None of intraocular inflammation in the study eye.
- Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese Academy of Medical Sciences & Peking Union Hospital — Beijing
Identifiers
NCT: NCT06839339 · AL-001-02