Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorBeijing Anlong Biopharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Enrolled in AL-001-01 study and received AL-001 ophthalmic injection.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
21 Participants
are grouped into 1 trial groupGroup A: The subjects received AL-001 ophthalmic injection
Trial outcomes
Primary outcomes
1
AE/SAE
Incidence and severity of ophthalmic and systematic AE/SAE.
Time frame
month 48Secondary outcomes
1
Best Corrected Visual Acuity(BCVA)
Change in BCVA from baseline
Time frame
month 482
The mean and frequency of anti-VEGF injections
The mean and frequency of subjects with wAMD receiving anti-VEGF injections
Time frame
month 48Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov