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Exudative Age-related Macular DegenerationPhase 4CyPovNCT02976194

Intraocular Cytokine in Recurrence of Polypoidal Choroidal Vasculopathy

A Phase 4 study testing ranibizumab in people with Exudative Age-related Macular Degeneration and Polypoidal Choroidal Vasculopathy, run by Pusan National University Hospital at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 50 years and older
What is being tested?
ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesSouth Korea
Study dates
22 Nov 2016to Jan 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Pusan National University Hospital

    Busan, 49241

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
ranibizumab
Medical subject headings
Polypoidal Choroidal Vasculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ranibizumabDrug

    Also called Lucentis

    Ranibizumab 0.5mg is injected into the vitreous cavity through the pars plana using 30 gauge (or narrower) needle-attached syringe.

Study groups in NCT02976194
Study groupRoleWhat they receive
pro-re-nataExperimentalRanibizumab 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.
Receives: Drug: ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of VEGF-A from 8 weeks to 20 weeks

    Intraocular concentration of VEGF-A is measured using multiplex immunoassay.

    Measured: 8 weeks and 20 weeks

Secondary outcomes (8)

  1. Changes of the other cytokines from 8 weeks to 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.

    Measured: 8 weeks and 20 weeks

  2. Changes of cytokines from baseline to 8 weeks

    Intraocular concentration of cytokines including VEGF, angiopoietin-1, IL-10, PDGF and PlGF is measured using multiplex immunoassay.

    Measured: baseline and 8 weeks

  3. Correlation between time to recurrence and cytokine concentration at 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.

    Measured: baseline and 8 weeks

  4. Correlation between vision changes and cytokine concentration changes

    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.

    Measured: baseline and 24 weeks.

  5. Correlation between CSMT and cytokine concentration

    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.

    Measured: baseline, 8 weeks and 20 weeks.

  6. Correlation between choroidal thickness and cytokine concentration

    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.

    Measured: baseline, 8 weeks and 20 weeks.

  7. Correlation between area of new vessels and cytokine concentration

    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.

    Measured: baseline

  8. Correlation between polyp closure and cytokine concentration changes

    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.

    Measured: baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2016 (estimated)
  2. Study start22 Nov 2016
  3. Primary completionNov 2019 (estimated)
  4. Study completionJan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02976194
Sponsor's protocol ID
2016-0186
Acronym
CyPov
Status last verified
Oct 2019
First submitted
22 Nov 2016
Last updated
10 Oct 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Cha DM, Woo SJ, Kim HJ, Lee C, Park KH. Comparative analysis of aqueous humor cytokine levels between patients with exudative age-related macular degeneration and normal controls. Invest Ophthalmol Vis Sci. 2013 Oct 25;54(10):7038-44. doi: 10.1167/iovs.13-12730.

    PubMed 24106111

  • Rezar-Dreindl S, Sacu S, Eibenberger K, Pollreisz A, Buhl W, Georgopoulos M, Krall C, Weigert G, Schmidt-Erfurth U. The Intraocular Cytokine Profile and Therapeutic Response in Persistent Neovascular Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2016 Aug 1;57(10):4144-50. doi: 10.1167/iovs.16-19772.

    PubMed 27537264

  • Hu J, Leng X, Hu Y, Atik A, Song X, Li Z, Liu Y, Lu L. The Features of Inflammation Factors Concentrations in Aqueous Humor of Polypoidal Choroidal Vasculopathy. PLoS One. 2016 Jan 22;11(1):e0147346. doi: 10.1371/journal.pone.0147346. eCollection 2016.

    PubMed 26799405

  • Sakurada Y, Nakamura Y, Yoneyama S, Mabuchi F, Gotoh T, Tateno Y, Sugiyama A, Kubota T, Iijima H. Aqueous humor cytokine levels in patients with polypoidal choroidal vasculopathy and neovascular age-related macular degeneration. Ophthalmic Res. 2015;53(1):2-7. doi: 10.1159/000365487. Epub 2014 Nov 29.

    PubMed 25472810

  • Tong JP, Chan WM, Liu DT, Lai TY, Choy KW, Pang CP, Lam DS. Aqueous humor levels of vascular endothelial growth factor and pigment epithelium-derived factor in polypoidal choroidal vasculopathy and choroidal neovascularization. Am J Ophthalmol. 2006 Mar;141(3):456-62. doi: 10.1016/j.ajo.2005.10.012.

    PubMed 16490490

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ranibizumab in people with Exudative Age-related Macular Degeneration and Polypoidal Choroidal Vasculopathy, run by Pusan National University Hospital at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of VEGF-A from 8 weeks to 20 weeks (time frame: 8 weeks and 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02976194, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.

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