Phase 1 study to determine the maximum tolerated dose and to assess the safety, pharmacokinetics, and efficacy of AVI-3207 Inj. in patients with neovascular age-related macular degeneratio
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0004887
- Lead Sponsor
- Avixgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 9
1) Age of 50 or older
2) Patients who agree to participate in this trial and voluntarily sign a written informed consent
3) Active* subfoveal choroidal neovascularization (CNV) caused by neovascular (wet) AMD; the patient must be expected to benefit from the study based on the judgment of the investigator.
* Active is defined as the presence of intraretinal or subretinal fluid confirmed by optical coherence tomography (OCT).
4) Best corrected visual acuity (BCVA) letter score =25-73 as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) VA chart (Snellen VA 20/320-20/40)
5) Maximum size of the neovascular lesion =12 MPS (macular photocoagulation study) disc area
1) Patients receiving ocular or systemic treatment on the study eye, including photodynamic therapy (PDT) or laser photocoagulation or surgical operation, within 3 months prior to screening for the treatment of neovascular macular degeneration (except functional foods and vitamins)
2) Patients who have previously received anti-vascular endothelial growth factor (VEGF) drugs for the treatment of neovascular macular degeneration in the study eye
* However, registration may be restricted at the investigator's discretion if the non-study eye is applicable to the following:
? Patients who have received anti-vascular endothelial growth factor (VEGF) drugs in the non-study eye within 3 months
before screening
? Patients who have received anti-vascular endothelial growth factor (VEGF) drugs in the non-study eye but had no drug
response at the time of administration
? Patients who have had problems with their daily life due to non-study eye after administration of anti-vascular endothelial
growth factor (VEGF) drugs
3) Patients who have received steroids within 1 month prior to screening
4) Macular scars or retinal pigment epithelial damage in the study eye
5) CNV in the study eye caused by other factors except AMD
6) Diabetic retinopathy
7) Diagnosis of retinal detachment or retinal break in the study eye
8) Uncontrolled glaucoma in the study eye (intraocular pressure = 25 mmHg despite antiglaucoma treatment)
9) Intraocular or periocular surgery on the study eye within 3 months prior to the screening visit
10) Cloudiness of crystalline lens and media that might affect the results of funduscopy, fluorescein angiography (FAG), and OCT
11) Hypersensitivity reactions to any of the components of the study drug
12) Confirmed or suspected ocular or periocular infection
13) Intraocular inflammation
14) Systemic infection
15) Uncontrolled hypertension
16) Any of the following conditions of renal impairment as defined by
?Serum creatinine above the normal level; or
?urine protein: urine creatinine ratio = 1
17) Diagnosis of unstable coronary artery disease, angina pectoris, congestive heart failure, or arrhythmia requiring active medical management within 1 month prior to screening
18) Diagnosis of myocardial infarction or acute heart failure within 6 months prior to screening
19) Patients who have received anticoagulants or antiplatelet drugs within 1 month prior to screening
20) History of malignant tumors within 5 years prior to screening (Subjects with malignant tumors that did not recur for =5 years are eligible. Subjects with basal cell carcinoma or cutaneous squamous cell carcinoma that did not recur after resections are also eligible.)
21) Diagnosis of peripheral arterial disease
22) Autoimmune disease
23) Non-healing wound, ulcer, or fracture
24) History of allergic reactions to contrast medium
25) Pregnant or lactating woman
26) A man or woman having planning pregnancy or childbearing potential who does not agree to using one of contraceptives listed below
? Surgical sterilization (e.g., bilateral tubal ligation, vasectomy)
? Hormonal contraceptives (implant, patch, oral)
? Double barrier method [concomitant use of two of the followings: Intrauterine device (IUD), male or female condom with spermicide, diaphragm, sponge, cervical cap]
Periodic abstinence (e.g., calendar method, ovulation method, basal body temperature method, post ovulation method) and external ejaculation are not acceptable as appropriate cont
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events confirmed by ophthalmologic examination (IOP measurement, funduscopy, and slit lamp microscopy);Status of abnormal light perception immediately after the investigational product dosing (5 and 30 minutes post-dose);Adverse events including subjective/objective symptoms;Frequency of endophthalmitis, retinal detachment, cataract, and uveitis
- Secondary Outcome Measures
Name Time Method