Long-term Follow-up Study of AL-001 Ophthalmic Injection... | NCT06718816

Studies
Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMD

NCT06718816

Sponsor

Beijing Anlong Biopharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Dec 5, 2024Actual

Enrollment

21Estimated

Phase

Not provided

Conditions

Wet Age-related Macular Degeneration (wAMD)

Interventions

Not provided

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2024Estimated

Primary Completion Date

Jun 30, 2029Estimated

Completion Date

Jun 30, 2029Estimated

First Submitted Date

Dec 2, 2024

First Submission Date that Met QC Criteria

Dec 2, 2024

First Posted Date

Dec 5, 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

Dec 2, 2024

Last Update Posted Date

Dec 5, 2024Actual

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 study is designed to evaluate long-term safety and efficacy of AL-001 ophthalmic injection following suprachoroidal space(SCS) administration in subjects with wAMD. Eligible patients, are those who were previously enrolled in a clinical study in which they received a single dose of AL-001 administered via suprachoroidal space injection.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The subjects received AL-001 ophthalmic injection		Evaluate long-term safety and efficacy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AE/SAE	Incidence and severity of ophthalmic and systematic AE/SAE.	month 48

Secondary Outcomes

Measure	Description	Time Frame
Best Corrected Visual Acuity(BCVA)	Change in BCVA from baseline	month 48
The mean and frequency of anti-VEGF injections	The mean and frequency of subjects with wAMD receiving anti-VEGF injections

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subjects enrolled in AL-001 study and received AL-001 ophthalmic injection.
The subject or their legal representative agrees to participate in this study and signs a written ICF.
The subjects are willing and able to follow planned visits and procedures.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Enrolled in AL-001-01 study and received AL-001 ophthalmic injection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AnlongBio	Contact	+86-010-80414166		info@anlongbio.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese Academy of Medical Sciences & Peking Union Hospital	Recruiting	Beijing	Beijing Municipality		China