Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
N/AClinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed-consent before any evaluation
Visual impairment due to active CNV,including predominantly classic CNV,minimallyclassic CNV,occult CNV with no classic component and PCV.
50 years old and older
Chinese
For study eye: screening and baseline BCVA scores both should be between 78 and 23words (including 78 and 23 words) (approximately equals to 20/30-20/320 sneeleenvision chart units) while tested at 4 meters with ETDRS vision chart.
Exclusion
Exclusion Criteria:
Have Stroke and myocardial infarction within 3 months before screening
Any active periocular and ocular infection and inflammation (including blepharitis,conjunctivitis, keratitis, scleritis, uveitis, intraocular inflammation) whilescreening and baseline.
Uncontrolled glaucoma (under treatment [IOP] ≥ 30 mm Hg or depend on researchers)while screening and baseline
Neovascularization of iris and neovascular glaucoma while screening and baseline
Any causes led to choroidal neovascularization except Wet AMD (including ICNV,centralserous chorioretinopathy,ocular histoplazmoza and pathologic myopia) while screeningand baseline
With structure injury (including vitreous macular traction,epiretinal membraneinvolving in central fovea,subretinal fibroplasia,laser scar and central foveaatrophy) within 0.5 optic disc diameter to the central of macula while screening andbaseline, which may harm the improvement of vision by treatment according toresearchers
Any systemic anti-VEGF medication(as Avastin) use within 3 months before screening
Any medication systemic use toxic to lens, retina and optic nerve,including ironamine, chloroquine/chloroquine (Plaquenil ®), tamoxifen, phenothiazine and ethambutol
For study eye:Used to accept following treatments for wet AMD within 3 months oraccept following treatments more than three times before baseline: a)Anti-angiogenesisdrugs(pegaptanib (Macugen®),ranibizumab ,bevacizumab(Avastin®),VEGF-Trap,KH902;b)Anecortave acetate corticosteroids;c)Proteinkinase C inhibitors,squalamine,siRNA; d)PDT (Visudyne®)treatment,external beamradiotherapy, local laser photocoagulation, vitrectomy, submacular surgery andtranspupillary thermotherapy
Any intraocular surgery(including YAG laser) within 3 months before baseline orpredicated within 6 months after baseline
Intraocular or periocular treatment of corticosteroids within 3 months before baseline
For follow eye:Any anti-angiogenesis treatment(including anti-VEGF,likeLucentis,Avastin® and KH902 ) within 3 months before baseline
Study Design
Study Description
Connect with a study center
Eye & Ent Hospital of Fudan University
Shanghai, 200080
ChinaActive - Recruiting
Shanghai 10th People's Hospital
Shanghai, 200080
ChinaActive - Recruiting
Shanghai First People's Hospital
Shanghai, 200080
ChinaActive - Recruiting
Shanghai Zhongshan Hospital
Shanghai, 200080
ChinaActive - Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200080
ChinaActive - Recruiting
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