The objective of this phase 2 study is to determine the optimal dose of ALS-L1023 by evaluating the safety and efficacy of ALS-L1023 comparing with placebo when used in combination with Ranibizumab for the treatment of wet age-related macular degeneration(AMD). The study is designed as multicenter, randomized, placebo-controlled, double-blind, three-arm parallel-group phase 2 study in patients with neovascular age-related macular degeneration. This study consists of two separate phases: a loading phase and a PRN(pro re nata) phase. Once the subject provides a written informed consent, subject information including demographics, medical history, and concomitant medications will be collected, and only those who meet the inclusion/exclusion criteria will participate in the study. All subjects who are enrolled in the study will be randomized into three groups Group A (Ranibizumab 0.5mg \& ALS-L1023 600mg) or Group B (Ranibizumab 0.5mg \& ALS-L1023 1200mg) or Group C (Ranibizumab \& placebo) in a 1:1:1 ratio. Randomization will be stratified by whether or not the subject has PCV(polypoidal choroidal vasculopathy) confirmed at Screening test. During the 3-month loading phase, all subjects will receive a Ranibizumab 0.5mg injection into the vitreous every month and take either the placebo or ALS-L1023 orally twice a day. During the following 3-12 month PRN phase, subjects will continue to take the placebo or ALS-L1023 in the same frequency as above but receive Ranibizumab injection only when it meets retreatment criteria. Subjects must instill antibacterial eye drops three times a day for three days after Ranibizumab injection. Subjects will visit the study site monthly during the 12 month study period in order to receive scheduled assessments and evaluate safety and efficacy of treatment. Image interpretation will be performed by a central reading center. The central reading center will confirm eligibility for enrollment and the discrimination of Polypoidal Choroidal Vasculopathy(PCV) at screening and play a role in interpreting whole images of all subjects after the end of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
ALS-L1023 is an active fraction extracted from Melissa officinalis L. (Labiatae; lemon balm) leaves.
LUCENTIS® (an anti-neovascular VEGF-A inhibitor) 0.5 mg, intravitreal injection
Control group for comparison with oral administration of ALS-L1023
AngioLab, Inc.
Daejeon, Daejeon Gwangyeogsi, South Korea
Mean change of Best Corrected Visual Acuity(BCVA).
Mean change of BCVA(Best Corrected Visual Acuity) as assessed by ETDRS(Early Treatment Diabetic Retinopathy Study) chart at a distance of 4 meters at month 12 compared with baseline.
Time frame: 12 months
Mean change in BCVA(at each visit)
Mean change in BCVA as assessed by ETDRS chart at a distance of 4 meters at each visit except month 12 compared with baseline.
Time frame: 12 months
Mean number of Ranibizumab re-administration
Mean number of Ranibizumab re-administration after Ranibizumab loading dose.
Time frame: 12 months
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