A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Three-arm Parallel-Group, 12-Month Study to Evaluate the Safety and Efficacy of ALS-L1023 Administered in Combination With Ranibizumab in Patients With Wet-AMD
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AngioLab, Inc.
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Mean change of Best Corrected Visual Acuity(BCVA).
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects aged 50 years or older;
- •Subjects who can give a written informed consent;
- •Subjects who have active, subfoveal choroidal neovascularization(CNV) Active indicates the confirmation of fluorescence leakage by FAG and the presence of intraretinal or subretinal fluid by optical coherence tomography(OCT);
- •Subjects whose area of fibrosis is less than 50% of total lesion area;
- •Subjects with BCVA letter score of 73-24 (20/40 to 20/320 Snellen Equivalent) using ETDRS chart measured at 4 meters distance;
- •Subjects who have a maximum lesion size of 12 optic-disk areas (1 optic-disk area equals 2.54 mm2 on the basis of 1 optic-disk diameter of 1.8 mm) with neovascularization.
- •Exclusion criteria:
- •Subjects who have any prior ocular or systematic treatment or surgery in the study eye for neovascular AMD like Photodynamic therapy(PDT), laser photocoagulation etc. except dietary supplements or vitamins;
- •Subjects who received any prior or concomitant therapy in the study eye with anti-VEGF therapy (for example Ranibizumab, Bevacizumab, Aflibercept etc.). This does not apply to treatment of the opposite eye;
- •Subjects whose total lesion size is ≥12 disc areas (30.5 mm2), including blood, scars, and neovascularization) as assessed by Fluorescein angiography(FAG) in the study eye;
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: ALS-L1023 (Drug)
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.
Intervention: Ranibizumab (Drug)
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.
Intervention: ALS-L1023 (Drug)
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.
Intervention: Ranibizumab (Drug)
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.
Intervention: Ranibizumab (Drug)
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.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Mean change of Best Corrected Visual Acuity(BCVA).
Time Frame: 12 months
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.
Secondary Outcomes
- Mean change in BCVA(at each visit)(12 months)
- Mean number of Ranibizumab re-administration(12 months)