NCT06707753Active, not recruitingPhase 1/2
Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with WAMD
An Open-label, Nonrandomized, Single-arm, Single Dose, Dose-escalation Phase I/IIa Study to Evaluate the Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)
Source: ClinicalTrials.gov · Last updated 19 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 25 Nov 2024
- Start date
- 11 Sept 2023
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Beijing Anlong Biopharmaceutical Co., Ltd.
- Diseases
- Macular degeneration
- NCT number
- NCT06707753
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 21
- From 11 Sept 2023 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
- History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
- Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
- Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.
Other
- Non-wAMD induced CNV or macular edema in the study eye.
- Uncontrolled glaucoma 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.
- None of intraocular inflammation in the study eye.
Who the study is looking for
- Age≥ 50 and ≤ 80.
- The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
- Best Corrected Visual Acuity (BCVA) of study eye during screening, Early Treatment of Diabetic Retinopathy Study (ETDRS) letters≤73 and ≥19.
- The subject or their legal representative agrees to participate in this study and signs a written ICF.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese Academy of Medical Sciences & Peking Union Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.