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

May 6, 2020 updated by: Xiaodong Sun

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200080
        • Shanghai General Hospital, Shanghai Jiao Tong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
Drug: Anti-VEGF drug
Conbercept or other anti-VEGF drugs
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
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
24 months
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.
21 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaodong Sun

Collaborators

Shanghai Zhongshan Hospital
Eye & ENT Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2020

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (ACTUAL)

May 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCV20200506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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