None listed
Conditions
Interventions
Drug : Application of three different dose (50, 100, 200 ug/eye) of AVI-3207 Inj. in a dose escalation manner (single intravitreal administration)
Sponsors
Avixgen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Vital signs, electrocardiogram (ECG), laboratory tests, physical examination;Mean change from baseline in Best Corrected Visual Acuity (BCVA) at Day 42 Visits based on Visual Acuity (VA) results using the ETDRS (Early Treatment Diabetic Retinopathy Study) Visual Acuity (VA) chart;Change from screening in central macular thickness measured by Optical Coherence Tomography (OCT) at Day 42 Visit;Mean change from baseline in Best Corrected Visual Acuity (BCVA) at Day 7, 14, and 28 Visits based on Visual Acuity (VA) results using the ETDRS (Early Treatment Diabetic Retinopathy Study) Visual Acuity (VA) chart;Change from screening in central macular thickness at Day 7, 14, and 28 Visits;Result from screening in quantified pigment epithelial tear and subretinal fluid measured by Optical Coherence Tomography (OCT) at Day 7, 14, 28, and 42 Visits;Change from screening in Choroidal Neovascularization (CNV) lesion size measured by OCT angiography at Day 7, 14, 28, and 42 Visits;Change from screening in Choroidal Neovascularization (CNV) lesion size measured by Fluorescein Angiography (FAG) at Day 42 Visit | — |
Countries
Korea, Republic of
Contacts
Public ContactUn Chul Park
Seoul National University Hospital
Outcome results
None listed