Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kyowa Kirin Co., Ltd.
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Voluntary written informed consent to participate in the study
Active subfoveal MNV (any subtype) or juxtafoveal/extrafoveal MNV secondary to AMD with a subfoveal component related to the MNV activity in the study eye as assessed by FA (evidence of leakage) or SD-OCT (presence of fluid) judged by the central reading center at screening
BCVA ETDRS letter score of 78 letters to 35 letters in the study eye as measured by the ETDRS visual acuity chart at screening
CST ≥ 450 μm at screening
You may not be if
Subretinal hemorrhage, fibrosis, or atrophy of \> 50% of the total lesion area and/or that involves the fovea in the study eye
Uncontrolled glaucoma in the study eye
Aphakia or pseudophakia with AC-IOL in the study eye
Active intraocular inflammation in the study eye
Any current ocular condition for which visual acuity loss would not improve from resolution of macular edema in the study eye
History of rhegmatogenous retinal detachment in the study eye
Any current or history of ocular disease other than nAMD in the study eye that may confound assessment of the macula or affect central vision
History of the following therapies in the study eye:
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
* Prior treatment PDT with Visudyne®, external-beam radiation therapy, transpupillary thermotherapy, or panretinal photocoagulation
* Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1
* Previous treatment with IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars;
* Treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks prior to Day 1. Previously treated patients who received these medications more than 12 weeks prior to Day 1 can be enrolled, but the patients should be diagnosed with nAMD within 3 years prior to Day 1
Any current or history of endophthalmitis in either eye
History of idiopathic or autoimmune-associated uveitis in either eye
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
