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Clinical Trials in China / NCT06707753
Active, not recruiting Phase 1/2

Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with WAMD

NCT06707753 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Anlong Biopharmaceutical Co., Ltd.
Phase
Phase 1/2
Started
2023-09-11
Last updated
2025-03-19

Condition(s) studied

Wet Age-related Macular Degeneration (wAMD)

Investigational drug(s) / intervention(s)

AL-001

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)

Trial sites (1)

FacilityCityRegionStatus
Chinese Academy of Medical Sciences & Peking Union Hospital Beijing China

More Beijing Anlong Biopharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

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.

View NCT06707753 on ClinicalTrials.gov ↗ ← All trials in China