KCT0004887
Recruiting
未知
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 degeneration
Avixgen0 sites9 target enrollmentTBD
ConditionsDiseases of the eye and adnexa
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the eye and adnexa
- Sponsor
- Avixgen
- Enrollment
- 9
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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