NCT02976194

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2016

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

2.9 years

First QC Date

November 22, 2016

Last Update Submit

October 8, 2019

Conditions

Exudative Age-related Macular DegenerationPolypoidal Choroidal Vasculopathy

Outcome Measures

Primary Outcomes (1)

  • Changes of VEGF-A from 8 weeks to 20 weeks

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

    8 weeks and 20 weeks

Secondary Outcomes (8)

  • Changes of the other cytokines from 8 weeks to 20 weeks

    8 weeks and 20 weeks

  • Changes of cytokines from baseline to 8 weeks

    baseline and 8 weeks

  • Correlation between time to recurrence and cytokine concentration at baseline and 8 weeks.

    baseline and 8 weeks

  • Correlation between vision changes and cytokine concentration changes

    baseline and 24 weeks.

  • Correlation between CSMT and cytokine concentration

    baseline, 8 weeks and 20 weeks.

  • +3 more secondary outcomes

Study Arms (1)

pro-re-nata

EXPERIMENTAL

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

Interventions

ranibizumabDRUG

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

Also known as: Lucentis
pro-re-nata

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Related Publications (5)

  • 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.

    PMID: 24106111BACKGROUND

  • 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.

    PMID: 27537264BACKGROUND

  • 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.

    PMID: 26799405BACKGROUND

  • 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.

    PMID: 25472810BACKGROUND

  • 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.

    PMID: 16490490BACKGROUND

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroidal NeovascularizationChoroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ji Eun Lee, MD, PhD

    Pusan National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 29, 2016

Study Start

November 22, 2016

Primary Completion

November 1, 2019

Study Completion

January 1, 2020

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)