Safety and Efficacy of Two Regimens of Ranibizumab 0.5 mg in Chinese Patients With Neovascular AMD

Last updated: November 3, 2016
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Trial Status Unknown

Phase

4

Condition

Macular Degeneration

Geographic Atrophy

Treatment

N/A

Clinical Study ID

NCT02810808
13411950400
  • Ages > 50
  • All Genders

Study Summary

The study will evaluate the efficacy and safety of two different dosing regimens of ranibizumab (0.5 mg on BCVA by 1+PRN vs 3+PRN) in Chinese patients with wet AMD. This study is to provide long-term safety data in the treatment of Chinese patients with wet AMD.

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

Total Participants: 115
Study Start date:
December 01, 2013
Estimated Completion Date:
January 31, 2017

Study Description

Inclusion Criteria: Age ≥ 50 y/o, nAMD patients(including PCV) Best-corrected visual acuity(BCVA) Exclusion Criteria: Previous anti-VEGF treatment within 3 months History of intraocular surgery within 3 months or arrangement of intraocular surgery in the next 6 months from baseline Active or recent intraocular inflammation in the study eye Primary Endpoint: Improvement in BCVA compared to baseline Other: Central Macular Thickness after Treatment,Numbers of Injections

Connect with a study center

  • Eye & Ent Hospital of Fudan University

    Shanghai, 200080
    China

    Active - Recruiting

  • Shanghai 10th People's Hospital

    Shanghai, 200080
    China

    Active - Recruiting

  • Shanghai First People's Hospital

    Shanghai, 200080
    China

    Active - Recruiting

  • Shanghai Zhongshan Hospital

    Shanghai, 200080
    China

    Active - Recruiting

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200080
    China

    Active - Recruiting

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