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A Study Comparing Efficacy and Safety of "Treat-and-Extend" Regimen Versus PRN of Conbercept in AMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02802657
Recruitment Status : Unknown
Verified June 2016 by Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : June 16, 2016
Last Update Posted : June 16, 2016
Sponsor:
Collaborators:
Eye & ENT Hospital of Fudan University
Shanghai Zhongshan Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Information provided by (Responsible Party):
Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
The study will evaluate the efficacy and safety of two different regimens of Conbercept (Treat-and-Extend Regimen vs. PRN) in patients with wet AMD. This study is to provide long-term safety data in the treatment of patients with wet AMD.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Procedure: Treat-and-Extend regimen Procedure: Pro Re Nata Drug: Conbercept Phase 4

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Study Comparing Efficacy and Safety of " Treat-and-Extend" Regimen Versus PRN Regimen of Conbercept in Neovascular Age-related Macular Degeneration
Study Start Date : July 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Conbercept 0.5mg Treat-and-Extend regimen

Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and Treat-and-Extend Regimen of the same dose guided by BCVA stabilization and OCT in the extension treatment period.

Intervention: Drug: Conbercept

Procedure: Treat-and-Extend regimen
For the T&E regimen,we recorded patients' data after retreatment by 3 monthly intravitreal injections of Conbercept. Patients were examined 6 weeks after the third injection, with ETDRS visual acuity testing, fundus ophthalmoscopy and photography, and OCT, and treated on the same day. The interval between treatments was extended by 2-week (12-week was a maximum) provided that OCT and fundus examination did not show either exudative manifestations or new macular hemorrhage or active CNV or reduced by 2 weeks (4-week was minimum) in case of such manifestations or hemorrhage. The persistence of pigment epithelium detachment was not considered a condition that justified shortening the interval between injections.
Other Name: T&E

Drug: Conbercept
Active Comparator: Conbercept 0.5mg Pro Re Nata

Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period.

Intervention: Drug: Conbercept

Procedure: Pro Re Nata
For the PRN group, we recorded patients'data after retreatment by 3 monthly intravitreal injections of Conbercept.Subsequent reinjections were given as needed according to the changes in patients'visual acuity and/or the exudation shown by OCT. Four to five weeks after the third and last injection, all patients in the PRN group underwent an examination, including ETDRS visual acuity, fundus photography,and OCT. In case of persistent subfoveal or perifoveal fluid, macular intraretinal edema, visual loss of >5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later.
Other Name: PRN

Drug: Conbercept



Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: 24 months ]
    Compare of Number of participants with treatment-related adverse events between the two groups to assess the safety of Treat-and-Extend regimen of Conbercept


Secondary Outcome Measures :
  1. Mean Snellen BCVA at every visit or treatment [ Time Frame: 24 months ]
    Compare of mean Snellen Best-Corrected-visual-acuity and mean central macular thickness by OCT at every visit or treatment between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.

  2. Mean number of injections after the initial three loading dose monthly injections [ Time Frame: 21 months ]
    Compare of mean number of injections after the initial three loading dose monthly injections between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.

  3. mean central macular thickness at every visit or treatment by OCT [ Time Frame: 24 months ]
    Compare of mean central macular thickness by OCT at every visit or treatment between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed-consent before any evaluation
  • Visual impairment due to active CNV,including predominantly classic CNV,minimally classic CNV,occult CNV with no classic component and PCV.
  • 50 years old and older
  • Chinese
  • For study eye: BCVA between 20/30 and 20/320 on electronic visual acuity texting at the time point of both screening and baseline.

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) while screening 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,central serous chorioretinopathy,ocular histoplazmoza and pathologic myopia) while screening and baseline
  • With structure injury (including vitreous macular traction,epiretinal membrane involving in central fovea,subretinal fibroplasia,laser scar and central fovea atrophy) within 0.5 optic disc diameter to the central of macula while screening and baseline, which may harm the improvement of vision by treatment according to researchers
  • 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 iron amine, chloroquine/chloroquine (Plaquenil ®), tamoxifen, phenothiazine and ethambutol
  • For study eye:Used to accept following treatments for wet AMD within 3 months or accept following treatments more than three times before baseline: a)Anti-angiogenesis drugs(pegaptanib (Macugen®),ranibizumab ,bevacizumab(Avastin®),VEGF-Trap,KH902;b)Anecortave acetate corticosteroids;c)Protein kinase C inhibitors,squalamine,siRNA; d)PDT (Visudyne®)treatment,external beam radiotherapy, local laser photocoagulation, vitrectomy, submacular surgery and transpupillary thermotherapy
  • Any intraocular surgery(including YAG laser) within 3 months before baseline or predicated 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,like Lucentis,Avastin® and KH902 ) within 3 months before baseline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802657


Contacts
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Contact: Xiaodong Sun +86-02163240090 ext 6822 xdsun@sjtu.edu.cn

Locations
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China
Eye & Ent Hospital of Fudan University Not yet recruiting
Shanghai, China, 200080
Contact: Lei Li, M.D.    +8613501844773    drlilei@163.com   
Shanghai First People's Hospital Not yet recruiting
Shanghai, China, 200080
Contact: Xiaodong Sun, M.D.    +86 21 63240090 ext 6822    xdsun@sjtu.edu.cn   
Principal Investigator: Xiaodong Sun, M.D.         
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, China, 200080
Shanghai Zhongshan Hospital
Shanghai, China, 200080
Sponsors and Collaborators
Xiaodong Sun
Eye & ENT Hospital of Fudan University
Shanghai Zhongshan Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Investigators
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Principal Investigator: Xiaodong Sun Shanghai General Hospital, Shanghai Jiao Tong University

Publications:

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Responsible Party: Xiaodong Sun, Professor and Executive Vicechair of Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02802657    
Other Study ID Numbers: 15216713049
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
Age-related Macular Degeneration
Conbercept
Treat-and-Extend Regimen
Pro Re Nata
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases