Evaluate the Safety and Efficacy of ALS-L1023 Administered in Combination with Ranibizumab in Patients with Neovascular(wet) Age-Related Macular Degeneration (AMD)
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0003361
- Lead Sponsor
- AngioLab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 126
1) Subjects aged 50 years or older;
2) Subjects who can give a written informed consent;
3) 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 OCT;
4) Subjects whose area of fibrosis is less than 50% of total lesion area;
5) Subjects with Best Corrected Visual Acuity(BCVA) letter score of 73-24 (20/40 to 20/320 Snellen Equivalent) using Early Treatment Diabetic Retinopathy Study(ETDRS) chart measured at 4 meters distance;
6) 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.
1) 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;
2) 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;
3) Subjects whose total lesion size is =12 disc areas (30.5 mm2), including blood, scars, and neovascularization) as assessed by FAG in the study eye;
4) Subjects who have sub-retinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded 270° by visible CNV);
5) Subjects who have scar or fibrosis making up >50% of the total lesion in the study eye;
6) Subjects who have scar, fibrosis, or atrophy involving the center of the fovea in the study eye;
7) Subjects who have presence of retinal pigment epithelial tears or rips involving the macula in the study eye;
8) Subjects with a history of any vitreous hemorrhage within 4 weeks prior to Screening in the study eye;
9) Subjects who have presence of other causes of CNV in the study eye;
10) Subjects who had prior vitrectomy in the study eye;
11) Subjects with a history of retinal detachment or treatment or surgery for retinal detachment in the study eye;
12) Subjects with any history of macular hole of stage 2 and above in the study eye;
13) Subjects who have any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection;
14) Subjcets diagnosed with diabetes who have diabetic retinopathy or HbA1c value of 8 or more at screening;
15) Subjects with a history or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye;
16) Subjects who have macular disease or media opacity (including cataracts and vitreous opacity) that can be affect vision at the time of AMD diagnosis according to investigator’ discretion;
17) Subjects who have hypersensitivity to investigational products or to drugs with similar chemical structures;
18) Subjects with infections/suspected infections in or around the eye;
19) Subjects who have severe intraocular inflammation;
20) Female subjects who are pregnant or breastfeeding;
21) Female subjects of childbearing age but are not using one or more of the following contraceptive methods:
•Surgically sterile (i.e. have had bilateral tubal ligation or vasectomy)
•Hormonal contraceptives (implant, patch, or oral)
•Double barrier contraception (must use two of the following: intrauterine device, male or female condoms with spermicide, diaphragm, contraceptive sponge, cervical cap)
•Periodic abstinence (i.e. calendar rhythm method, Billings Ovulation Method, and basal body temperature) and withdrawal method are not considered as appropriate contraceptive methods, and subjects must continue to use effective methods of contraception throughout the study and for 30 days after the end of the study;
22) Subjects who experienced cardiovascular or cerebrovascular events within 12 months prior to Screening;
23) Subjects who have any clinically significant medical condition
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Mean change in BCVA as assessed by ETDRS chart at a distance of 4 meters at each visit except month 12 compared with baseline;Mean number of Ranibizumab re-administration