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Efficacy and Safety of Two Regimens of Anti-VEGF Therapy in Chinese Patients With Polypoidal Choroidal Vasculopathy

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ClinicalTrials.gov Identifier: NCT04380974
Recruitment Status : Not yet recruiting
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
Sponsor:
Collaborators:
Eye & ENT Hospital of Fudan University
Shanghai Zhongshan Hospital
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 anti-VEGF Therapy (OCTA plus OCT guided 3+PRN vs. OCT guided 3+PRN) in Chinese patients with PCV. This study is to provide long-term safety data in the treatment of Chinese patients with PCV.

Condition or disease Intervention/treatment Phase
Polypoidal Choroidal Vasculopathy Procedure: OCTA plus OCT guided 3+PRN regimen Procedure: OCT guided 3+PRN regimen Drug: Anti-VEGF drug Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Random, Open-label Multicenter, Phase IV Study Assessing the Efficacy and Safety of Two Regimens of Anti-VEGF Therapy in Chinese Patients With Polypoidal Choroidal Vasculopathy
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: OCTA plus OCT guided 3+PRN regimen
Monthly intravitreal injections of anti-VEGF drug in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization, OCTA and OCT in the extension treatment period.
Procedure: OCTA plus OCT guided 3+PRN regimen

For the OCTA plus OCT guided 3+PRN regimen, we recorded patients' data after retreatment by 3 monthly intravitreal injections of anti-VEGF drug. Subsequent reinjections were given as needed according to the changes in patients' visual acuity, activity of PCV lesions shown by OCTA and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this group underwent an examination, including ETDRS visual acuity, fundus photography, OCTA and OCT.

In case of BVN increased or polypoidal lesion progressed on OCTA scans, persistent subfoveal or perifoveal fluid, macular intraretinal edema on OCT scans, or 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.


Drug: Anti-VEGF drug
Conbercept or other anti-VEGF drugs

Active Comparator: OCT guided 3+PRN regimen
Monthly intravitreal injections of anti-VEGF drug in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization and OCT in the extension treatment period.
Procedure: OCT guided 3+PRN regimen

For the OCT guided 3+PRN group, we recorded patients'data after retreatment by 3 monthly intravitreal injections of Anti-VEGF drugs. Subsequent reinjections were given as needed according to the changes in patients'visual acuity and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this 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.


Drug: Anti-VEGF drug
Conbercept or other anti-VEGF drugs




Primary Outcome Measures :
  1. PCV lesion recurrence [ Time Frame: 24 months ]
    PCV lesion recurrence is defined as the reappearance of new exudative biomakers (such as IRF, SRF, PED) or new hemorrhage detected on OCT or fundus examination in subsequent visits from the last visit showing clinical stability. PCV lesion recurrence rate will be compared at 24months between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.


Secondary Outcome Measures :
  1. Mean Snellen BCVA at every visit or treatment [ Time Frame: 24 months ]
    Compare of mean Snellen Best-Corrected-visual-acuity at every visit or treatment between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.

  2. 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 OCTA plus OCT guided 3+PRN regimen

  3. 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 OCTA plus OCT guided 3+PRN regimen.

  4. 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 OCTA plus OCT guided 3+PRN regimen.



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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 PCV, including type 1 PCV and type 2 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 PCV (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 PCV within 3 months or accept following treatments more than three times before baseline:

    1. Anti-angiogenesis drugs (pegaptanib, ranibizumab, bevacizumab),VEGF-Trap;
    2. Anecortave acetate corticosteroids;
    3. Protein kinase C inhibitors, squalamine, siRNA;
    4. 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): NCT04380974


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

Locations
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China
Shanghai General Hospital, Shanghai Jiao Tong University
Shanghai, China, 200080
Contact: Xiaodong Sun    +86-02163240090 ext 6822      
Sponsors and Collaborators
Xiaodong Sun
Eye & ENT Hospital of Fudan University
Shanghai Zhongshan Hospital
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: NCT04380974    
Other Study ID Numbers: PCV20200506
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
Polypoidal Choroidal Vasculopathy
Optical coherence tomography angiography
Optical coherence tomography
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors