A multi-center, randomized, double-blinded, placebo-controlled, dose-exploratory, parallel Phase ?a clinical trial to evaluate the efficacy and safety by treating CU03-1001 Tablet for 12 weeks in patients with wet Age-related Macular Degeneratio
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0004815
- Lead Sponsor
- Curacle
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 75
Subjects must meet all of the following inclusion criteria to be eligible.
1) Subjects aged 50 years or older.
2) Subject who give voluntary consent to the study participation.
3) Subject who was eligible (inclusive of abnormality that is clinically not significant) for the study based on laboratory test and electrocardiogram test.
4) Subject who showed insufficient response to existing anti-VEGF treatment (Inclusive of Lucentis, Eylea and Avastin).
Insufficient response
For the purpose of maintenance therapy of existing anti-VEGF treatment,
a. Effusive change on SD-OCT such as retinal edema, subretinal fluid and etc is not eradicated despite more than 3 consecutive injections, which is a conventional treatment.
b. OR new Retinal hemorrhage or subretinal hemorrhage occurred during maintenance treatment.
5) Subject who does not smoke or has quit smoking for more than 3 months before screening.
Eyeball Inclusion Criteria for subjects at screening:
6) Patients with Wet Age-related Macular Degeneration that affects center of Macular.
Subject who had effusive change including subretinal fluid, retinal fluid, Retinal haemorrhage and Subretinal hemorrhage caused by Choroidal NeoVascularization(CNV), Polypoidal Choroidal Vasculopathy(PCV) or Retinal Angiomatous Proliferation, (RAP) as a result of tests such as Fundus examination, Fluorescein Angiography (FAG), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT) and etc.
7) Subject with Best Corrected Visual Acuity (BCVA) score from 4 m distance is 25~73 letters by use of ETDRS or similar visual acuity chart (equivalent to Snellen eye chart 20/40~20/320)
Subjects exhibiting any of the following will not be qualified for the study:
1) Subjects who have medical history of stroke or myocardial infarction within 3 months from the point of screening.
2) Subjects who have a Systolic blood pressure > 160 mmHg or Diastolic blood pressure > 100 mmHg at the point of screening.
3) Subjects with HbA1c value exceeds 10% at the point of screening.
4) Subjects who shows clinical test results as follows at the point of screening.
-ALT (Alanine aminotransferase) or AST (Aspartate aminotransferase)
exceeds 3 times the upper limit of normal.
-Subject with serious kidney disease (Serum creatinine > 1.5 mg/dL)
5) Subjects who have hypersensitivity against components of investigational product.
6) Subjects with gastrointestinal absorption disorder that may affect absorption of investigational product.
7) Subjects with medical history of alcohol or drug abuse within 2 years from the point of screening.
8) Female who is pregnant or breast-feeding or plans to get pregnant during study period and for 30 days after last administration day of investigational product.
9) Female who has childbearing potential as she doesn’t agree to use contraceptive methods‡ that are accepted by this protocol
; But, child bearing potential female who didn’t undergo sterilization surgery is allowed to join only when showed negative result from pregnancy status test, and should agree to maintain an effective contraceptive method during the whole study period and for 30 days from last administration day of investigational product.
‡ Accepted contraceptive methods are intrauterine contraception device or Implant of intrauterine system, double barrier contraception (spermicide and condom and contraceptive diaphragm, vaginal sponge or cervical cap), sterilization surgery, and complete abstinence. Hormonal contraceptive is not accepted.
‡ Periodic abstinence (for example: Calendar method, ovulation method, symptothermal method, post-ovulation methods) and abstinence are not considered as accepted contraceptive methods, and external ejaculation is not accepted.
10)Subjects who are considered as not eligible for study participation by principal investigator or study personnel’s decision.
Eyeball Exclusion Criteria for subjects at screening:
11) Subjects who were administered anti-VEGF treatment (Inclusive of Lusentis, Eylea and Avastin) within recent two months from the start day of investigational product administration.
12) Subjects who have infections or inflammation around active eyeball or in both eyeballs.
13) Subjects with uncontrolled glaucoma (by investigator’s decision oR currently under medication and eye pressure is = 25 mmHg) in the assigned eyeball
14) Subjects with Subretinal hemorrhage, atrophy or fibrosis from more than 50% of total lesion in the assigned eyeball
15) Subjects with medical history of Focal or Grid Pattern Laser Photocoagulation with Macular involvement or Photodynamic Therapy (PDT) within recent 3 months from the start day of investigational product administration in the assigned eyeball
16) Subjects with ophthalmologic disease that may cause confusion for outcome assessment of this study and consequently lead to decreased vision (for example: Retinal detachment, Epiretinal Membrane that may significantly affect vision or cataract that may need surgery during study period and etc.)
17) Subjects with Diabetic Retinopathy of more than Moderate non-proliferative Diabetic Retinopat
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Central macular thickness change amount by SD-OCT
- Secondary Outcome Measures
Name Time Method Ratio of subjects who used Rescue therapy;Change in BCVA measurement by ETDRS chart in 4 m distance;Ratio of subjects who completely lose retinal fluid and subretinal fluid measured by SD-OCT;Ratio of subjects who shows more than 1 line of improved vision (Based on ETDRS chart 5 letter) in 4 m distance;4)Ratio of subjects who shows more than 3 lines of decreased vision (Based on ETDRS chart 15 letter) in 4 m distance