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

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
OCTA plus OCT guided 3+PRN regimen
OCT guided 3+PRN regimen
Anti-VEGF drug
Sponsored by
Xiaodong Sun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy focused on measuring Polypoidal Choroidal Vasculopathy, Optical coherence tomography angiography, Optical coherence tomography

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai General Hospital, Shanghai Jiao Tong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OCTA plus OCT guided 3+PRN regimen

OCT guided 3+PRN regimen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PCV lesion recurrence
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

Mean Snellen BCVA at every visit or treatment
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.
Number of participants with treatment-related adverse events
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
Mean number of injections after the initial three loading dose monthly injections
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.
Mean central macular thickness at every visit or treatment by OCT
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.

Full Information

First Posted
May 6, 2020
Last Updated
May 6, 2020
Sponsor
Xiaodong Sun
Collaborators
Eye & ENT Hospital of Fudan University, Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04380974
Brief Title
Efficacy and Safety of Two Regimens of Anti-VEGF Therapy in Chinese Patients With Polypoidal Choroidal Vasculopathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaodong Sun
Collaborators
Eye & ENT Hospital of Fudan University, Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypoidal Choroidal Vasculopathy
Keywords
Polypoidal Choroidal Vasculopathy, Optical coherence tomography angiography, Optical coherence tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OCTA plus OCT guided 3+PRN regimen
Arm Type
Experimental
Arm Description
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.
Arm Title
OCT guided 3+PRN regimen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
OCTA plus OCT guided 3+PRN regimen
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
OCT guided 3+PRN regimen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Anti-VEGF drug
Intervention Description
Conbercept or other anti-VEGF drugs
Primary Outcome Measure Information:
Title
PCV lesion recurrence
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Mean Snellen BCVA at every visit or treatment
Description
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.
Time Frame
24 months
Title
Number of participants with treatment-related adverse events
Description
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
Time Frame
24 months
Title
Mean number of injections after the initial three loading dose monthly injections
Description
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.
Time Frame
21 months
Title
Mean central macular thickness at every visit or treatment by OCT
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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: Anti-angiogenesis drugs (pegaptanib, ranibizumab, bevacizumab),VEGF-Trap; Anecortave acetate corticosteroids; Protein kinase C inhibitors, squalamine, siRNA; 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Sun
Phone
+86-02163240090
Ext
6822
Email
xdsun@sjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Sun
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai General Hospital, Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Sun
Phone
+86-02163240090
Ext
6822

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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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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