Safety and Tolerability of AL-001 Ophthalmic Injection in... | NCT06707753

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

NCT06707753

Sponsor

Beijing Anlong Biopharmaceutical Co., Ltd.

Status

Active, not recruiting

Last Update Posted

Mar 19, 2025Actual

Enrollment

21Estimated

Phase

Phase 1Phase 2

Conditions

Wet Age-related Macular Degeneration (wAMD)

Interventions

AL-001

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2023Actual

Primary Completion Date

Aug 31, 2025Estimated

Completion Date

Aug 31, 2025Estimated

First Submitted Date

Nov 25, 2024

First Submission Date that Met QC Criteria

Nov 25, 2024

First Posted Date

Nov 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2025

Last Update Posted Date

Mar 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AL-001 Dose 1	Experimental	Injection of low dose	Drug: AL-001
AL-001 Dose 2	Experimental	Injection of medium dose	Drug: AL-001
AL-001 Dose 3	Experimental	Injection of high dose	Drug: AL-001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AL-001	Drug	Administered via suprachoroidal space injection.	AL-001 Dose 1 AL-001 Dose 2 AL-001 Dose 3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Non-wAMD induced CNV or macular edema in the study eye.
Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
Uncontrolled glaucoma in the study eye.
History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery 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.
Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
None of intraocular inflammation in the study eye.
Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided