Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-85
SponsorBeijing Anlong Biopharmaceutical Co., Ltd.
About this trial
This Phase II study is designed to evaluate the efficacy and safety of AL-001 ophthalmic injection 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 be randomized in Cohorts 1 and 2 to receive AL-001 administered via suprachoroidal space injection, Cohort 3 to receive Aflibercept.
Eligibility criteria
Qualifiers
Age≥ 50 and ≤ 85.
The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
The study eye has response to anti-VEGF injections.
The subject or their legal representative agrees to participate in this study and signs a written ICF.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AL-001
- Aflibercept
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov