Evaluation of the Safety and Efficacy of ALS-L1023 Administered in Combination With Ranibizumab in Patients With Wet-AMD

Sponsor
AngioLab, Inc.
Study ID
NCT03725501
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ALS-L1023 — DRUG
    ALS-L1023 is an active fraction extracted from Melissa officinalis L. (Labiatae; lemon balm) leaves.
  • Ranibizumab — DRUG
    LUCENTIS® (an anti-neovascular VEGF-A inhibitor) 0.5 mg, intravitreal injection
  • Placebo — OTHER
    Control group for comparison with oral administration of ALS-L1023

Study Details

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.

Key Dates

First listed
Oct 31, 2018
Start date
Dec 7, 2018
Status verified
Aug 2022
Primary completion
Jun 22, 2021
Completion
Jun 22, 2021

Study Design

Enrollment
126 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab + ALS-L1023 600mg
    * ALS-L1023 600 mg - Take 2 tablets orally twice a day. * Ranibizumab (Lucentis®) * Loading Phase (3 months): Intravitreally inject 0.5 mg of Ranibizumab/0.05 mL monthly. * PRN Phase (9 months): It should only be administered to subjects who meet the re-administered criteria.
  • Experimental: Ranibizumab + ALS-L1023 1200mg
    * ALS-L1023 1200 mg - Take 2 tablets orally twice a day. * Ranibizumab (Lucentis®) * Loading Phase (3 months): Intravitreally inject 0.5 mg of Ranibizumab/0.05 mL monthly. * PRN Phase (9 months): It should only be administered to subjects who meet the re-administered criteria.
  • Placebo Comparator: Ranibizumab + Placebo
    * Placebo - Take 2 tablets orally twice a day. * Ranibizumab (Lucentis®) * Loading Phase (3 months): Intravitreally inject 0.5 mg of Ranibizumab/0.05 mL monthly. * PRN Phase (9 months): It should only be administered to subjects who meet the re-administered criteria.

Primary Outcome Measure

Mean change of Best Corrected Visual Acuity(BCVA). [ Time Frame: 12 months ]

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