Phase
Condition
Macular Degeneration
Myopia
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able to read (or, if unable to read due to visual impairment, be read to verbatim bythe person administering the informed consent form or a family member) and understandthe informed consent form and willing to sign the informed consent form
Signed informed consent form. In Japan only, the informed consent form for a subjectunder the age of 20 years will require the co-signature of the subject's legallyauthorized representative.
Men and women ≥ 18 years of age
Myopia of greater than or equal to -6 D OR axial length of greater than or equal to 26.5 mm
Active subfoveal or juxtafoveal (within 1 to 199 μm of the center of the fovea) CNVsecondary to pathologic myopia as defined by leakage on FA
Best-corrected visual acuity of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200)in the study eye at 4 meters
Decrease in vision in the study eye is determined by the investigator, using his/hermedical judgment, to be primarily the result of the current active mCNV
Willing, committed, and able to return for all clinic visits and complete allstudy-related procedures
Exclusion
Exclusion Criteria:
Only one functional eye
Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
Greatest linear dimension (GLD) of the lesion in the study eye is greater than 12 discareas
Recurrent mCNV in the study eye
Aphakia in the study eye
History or presence of CNV with an origin other than pathologic myopia in the studyeye
Ocular inflammation or external ocular inflammation in the study eye
Concurrent disease in the study eye that would compromise BCVA or require medical orsurgical intervention during the study period
Any ocular disorder in the study eye that, in the opinion of the investigator, mayconfound interpretation of the study results
Significant scarring or atrophy in the fovea that indicates substantial irreversiblevision loss in the study eye
History of idiopathic or autoimmune-associated uveitis in either eye
Evidence at examination of infectious blepharitis, keratitis, scleritis, orconjunctivitis in either eye or current treatment for serious systemic infection
Vitreomacular traction or traction retinal detachment, epiretinal membrane in eithereye
Any iris neovascularization and/or vitreous hemorrhage in either eye
Uncontrolled glaucoma, or previous filtration surgery in either eye
Prior and concomitant treatments
In the study eye:
Any prior or concomitant treatment with another investigational agent for mCNV
Any previous panretinal photocoagulation or subfoveal thermal laser therapy
Any prior treatment with photodynamic therapy
Cataract surgery within 3 months prior to Day 1
Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1
Any other intraocular surgery within 3 months prior to Day 1
History of vitreoretinal surgery and/or scleral buckle surgery
Any prior treatment with anti-VEGF agents
Previous use of intraocular or periocular corticosteroids in either eye within 3months prior to Day 1
Previous assignment to treatment during this study
Uncontrolled hypertension
History of cerebrovascular disease or myocardial infarction within 6 months prior toBaseline/Day 1
History of other disease, metabolic dysfunction, physical examination finding, orclinical laboratory finding giving reasonable suspicion of a disease or condition thatcontraindicates the use of an investigational drug, may affect interpretation of theresults of the study, or renders the subject at high risk from treatment complications
Women of childbearing potential without contraception, women who intend to breastfeedduring the study. All subjects (both men and women) of childbearing potential who areunwilling to use adequate birth control measures during the course of the study.
Renal failure requiring dialysis or renal transplant
Participation in an investigational study within 30 days prior to Screening/Visit 1that involved treatment with any drug (excluding vitamins and minerals) or device
Known serious allergy to the fluorescein sodium for injection in angiography orVerteporfin
Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality
Study Design
Connect with a study center
Kowloon,
Hong KongSite Not Available
Nagoya, Aichi 466-8560
JapanSite Not Available
Urayasu, Chiba 279-0021
JapanSite Not Available
Matsuyama, Ehime 790-8524
JapanSite Not Available
Sendai, Miyagi 984-8560
JapanSite Not Available
Suita, Osaka 565-0871
JapanSite Not Available
Otsu, Shiga 520-2192
JapanSite Not Available
Bunkyo-ku, Tokyo 113-8519
JapanSite Not Available
Chiyoda-ku, Tokyo 101-8309
JapanSite Not Available
Shinjuku-ku, Tokyo 160-8582
JapanSite Not Available
Fukuoka, 812-8582
JapanSite Not Available
Fukushima, 960-1295
JapanSite Not Available
Kyoto, 606-8507
JapanSite Not Available
Osaka, 545-8586
JapanSite Not Available
Seoul, 137 701
Korea, Republic ofSite Not Available
Singapore, 168751
SingaporeSite Not Available
Taipei, 11217
TaiwanSite Not Available
Taoyuan, 333
TaiwanSite Not Available
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