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

Beijing Anlong Biopharmaceutical Co., Ltd.21 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Chinese Academy of Medical Sciences & Peking Union Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

AE/SAE

Incidence and severity of ophthalmic and systematic AE/SAE.

Time frame: month 48

Secondary Outcomes

Best Corrected Visual Acuity(BCVA)

Change in BCVA from baseline

Time frame: month 48

The mean and frequency of anti-VEGF injections

The mean and frequency of subjects with wAMD receiving anti-VEGF injections

Time frame: month 48

Central Contacts

AnlongBio

CONTACT

+86-010-80414166 info@anlongbio.com

Data from ClinicalTrials.gov

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