AL-001: Administered via suprachoroidal space injection.
Study summary
This Phase I/IIa study is designed to evaluate the safety, tolerability, preliminary pharmacodynamics and pharmacokinetics 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 receive a single dose of AL-001 administered via suprachoroidal space injection.
Eligibility
Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age≥ 50 and ≤ 80.
2. The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
3. Best Corrected Visual Acuity (BCVA) of study eye during screening, Early Treatment of Diabetic Retinopathy Study (ETDRS) letters≤73 and ≥19.
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.
Primary outcome measure(s)
Safety and tolerability — Week 24 Incidence of adverse events (AEs) and serious adverse events (SAEs)
Trial sites (1)
Facility
City
Region
Status
Chinese Academy of Medical Sciences & Peking Union Hospital
Beijing
China
More Beijing Anlong Biopharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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