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

Launched by BEIJING ANLONG BIOPHARMACEUTICAL CO., LTD. · Feb 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AL-001, which is an injection given in the eye to help people with wet age-related macular degeneration (wAMD). This condition can cause vision loss due to abnormal blood vessel growth in the eye. The trial aims to find out if AL-001 is effective and safe for patients who have shown some improvement with previous treatments that target a protein called VEGF. Participants will be divided into groups, with some receiving AL-001 and others receiving a different medication called Aflibercept for comparison.

To join the trial, participants need to be between 50 and 85 years old and have a specific type of eye problem related to wAMD. They should also have responded well to earlier VEGF treatments. However, certain eye conditions or past surgeries might make someone ineligible. If you choose to participate, you would receive the treatment through an injection in the eye and be monitored for any effects. It's important to know that this trial is not yet recruiting, so there will be more information available once it starts.

Gender

ALL

Eligibility criteria

• 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.