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)

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06707753

Enrollment

Registered

2024-11-27

Start date

2023-09-11

Completion date

2025-08-31

Last updated

2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Age-related Macular Degeneration (wAMD)

Brief 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.

Interventions

DRUGAL-001

Administered via suprachoroidal space injection.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability	Week 24	Incidence of adverse events (AEs) and serious adverse events (SAEs)

Secondary

Measure	Time frame	Description
Evaluate the effect of AL-001 on BCVA	Week 52	Mean change from baseline in BCVA

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026