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

ConditionWet Age-related Macular Degeneration (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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • AL-001

    Drug

    Administered via suprachoroidal space injection.

  • Aflibercept

    Drug

    Intravitreal injection

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: AL-001 Dose 1Experimental treatment 1 intervention
Group B: AL-001 Dose 2Experimental treatment 1 intervention
Group C: AfliberceptActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the effect of AL-001 on BCVA

Change in BCVA

Time frame
Week 24

Secondary outcomes

1

Safety

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Time frame
Week 56
2

Evaluate the effect of AL-001 on central retinal thickness (CRT)

Mean change from baseline in CRT as measured

Time frame
Week 56

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anlong Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: