Intraocular Cytokine in Recurrence of Polypoidal Choroidal Vasculopathy (CyPov)

October 8, 2019 updated by: Pusan National University Hospital

Intraocular Cytokine Changes in Recurrence of Polypoidal Choroidal Vasculopathy

Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of ranibizumab.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

PCV is regarded as a subtype of age-related macular degeneration (ARMD), but has several different features such as polypoidal terminal of new vessels, and relative resistance to anti-VEGF treatment. Other cytokines then VEGF are thought to be associated with development and progression of the disease. The aim of the this study is to investigate intraocular cytokines related to recurrence of polypoidal choroidal vasculopathy. Aqueous humor will be sampled from the anterior chamber at baseline, after loading injections of ranibizumab and at recurrence. The concentration of various cytokines will be measured in the aqueous humor.

Study Type

Interventional

Enrollment (Anticipated)

28

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

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital

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:

  1. Submacular PCV diagnosed based on branching neovascular networks having polypoidal dilatation in ICGA.
  2. Presence of exudative changes involving the fovea in OCT
  3. Decreased visual acuity to 20/320 - 20/40 to be primarily the results of PCV in the study eye.
  4. Willing and able to comply with clinic visits and study-related procedures, and provide a signed informed consent form.

Exclusion Criteria:

  1. Extramacular PCV.
  2. Presence of pathologic changes blocking 50% or more area of the lesion in angiography.
  3. Any anti-VEGF treatment in the study eye within 180 days of day 1.
  4. Previous photodynamic therapy in the study eye.
  5. History of intraocular surgery except uncomplicated cataract surgery performed before 90 days or more from day 1.
  6. Presence of exudative ARMD requiring anti-VEGF treatment in the other eye.
  7. Presence of other ocular disease that may compromise visual acuity in the study eye.
  8. Uncontrolled systemic disease.
  9. Active intraocular or periocular infection.
  10. Active intraocular inflammation.
  11. Hypersensitivity to ranibizumab or excipients.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pro-re-nata
Ranibizumab 0.5mg is injected in to the vitreous cavity. An injection is given every 4 weeks three times, and then the patient will be followed up every 4 weeks. An addition injection is given as needed. Recurrence is defined as increase of exudative changes, or increase of 10% or more in central subfield macular thickness (CSMT) measured using optical coherence tomography. Aqueous humor is sampled from the anterior chamber before injection at baseline, 8 weeks and 20 weeks.
Drug: ranibizumab
Ranibizumab 0.5mg is injected into the vitreous cavity through the pars plana using 30 gauge (or narrower) needle-attached syringe.
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of VEGF-A from 8 weeks to 20 weeks
Time Frame: 8 weeks and 20 weeks
Intraocular concentration of VEGF-A is measured using multiplex immunoassay.
8 weeks and 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of the other cytokines from 8 weeks to 20 weeks
Time Frame: 8 weeks and 20 weeks
Intraocular concentration of the other cytokines including angiopoietin-1, interleukin-10 (IL-10), platelet-derived growth factor (PDGF) and placental growth factor (PlGF) is measured using multiplex immunoassay.
8 weeks and 20 weeks
Changes of cytokines from baseline to 8 weeks
Time Frame: baseline and 8 weeks
Intraocular concentration of cytokines including VEGF, angiopoietin-1, IL-10, PDGF and PlGF is measured using multiplex immunoassay.
baseline and 8 weeks
Correlation between time to recurrence and cytokine concentration at baseline and 8 weeks.
Time Frame: baseline and 8 weeks
Time to recurrence is defined as number of weeks from 8 to recurrence. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation.
baseline and 8 weeks
Correlation between vision changes and cytokine concentration changes
Time Frame: baseline and 24 weeks.
Visual acuity is assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher score represents better functioning. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation.
baseline and 24 weeks.
Correlation between CSMT and cytokine concentration
Time Frame: baseline, 8 weeks and 20 weeks.
CSMT is central 1mm thickness of the macula measured using spectral-domain optical coherence tomography (OCT). Normal thickness is around 250μm. Increased CSMT is regarded as increase of en exudative sign. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation.
baseline, 8 weeks and 20 weeks.
Correlation between choroidal thickness and cytokine concentration
Time Frame: baseline, 8 weeks and 20 weeks.
Choroidal thickness is thickness of the choroid measured at the foveal center using spectral-domain OCT. Increased choroidal thickness was reported to be related to poor response to anti-VEGF treatment. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation.
baseline, 8 weeks and 20 weeks.
Correlation between area of new vessels and cytokine concentration
Time Frame: baseline
Area of new vessels is measured in indocyanine green angiography (ICGA) obtained at baseline. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation.
baseline
Correlation between polyp closure and cytokine concentration changes
Time Frame: baseline and 8 weeks
Polyp closure is defined as disappearance of polypoidal terminal in new vessels assessed in ICGA at 8 weeks. The difference of cytokine concentration is assessed between the closed group and un-closed group using non-parametric analysis, or Mann-Whitney U test.
baseline and 8 weeks

Collaborators and Investigators

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

Sponsor

Pusan National University Hospital

Collaborators

Novartis

Investigators

  • Principal Investigator: Ji Eun Lee, MD, PhD, Pusan National University Hospital

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 (Actual)

November 22, 2016

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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