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Status unknownNCT01360151Updated May 30, 2011

Aqueous Humor Level of Cytokines in Polypoidal Choroidal Vasculopathy and Change of Cytokines After Photodynamic Therapy

An interventional study of ranibizumab(Lucentis), verteporfin(Visudyne) in Polypoidal Choroidal Vasculopathy, sponsored by Seoul St. Mary's Hospital. Status unknown at 1 site in South Korea. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-30.

Sponsored by Seoul St. Mary's Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Apr 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study summary

This is a prospective, comparative control analysis. The investigators want to evaluate the aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal vasculopathy and the effect of photodynamic therapy and combination treatment of photodynamic therapy and Lucentis (Ranibizumab)on the level of vascular endothelial growth factor.

Read the detailed description

To compare the effect of combination therapy of intravitreal injection of Lucentis™ and photodynamic therapy versus only photodynamic therapy on aqueous humor vascular endothelial growth factor level in polypoidal choroidal vasculopathy patients to establish the vascular endothelial growth factor expression after photodynamic therapy and the direct effect of Lucentis™ on this increased vascular endothelial growth factor level. Additionally the investigators want to examine the vascular endothelial growth factor , tumor necrosis factor alpha, interleukin-2, interleukin-6 and interleukin-8 level of aqueous humor in symptomatic, active polypoidal choroidal vasculopathy patients.

02

Conditions studied

  • Polypoidal Choroidal Vasculopathy

Keywords

  • VEGF (Vascular endothelial growth factor)
03

In context

Polypoidal Choroidal Vasculopathy

56 studies on the registry are indexed under Polypoidal Choroidal Vasculopathy; 5 are open to participants now.

This study's planned enrollment of 16 is below the median of 50 across 41 interventional studies indexed under Polypoidal Choroidal Vasculopathy.

Browse Polypoidal Choroidal Vasculopathy studies →

Lead sponsor

Seoul St. Mary's Hospital is the lead sponsor of 75 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

\<Polypoidal choroidal vasculopathy group>

Inclusion criteria

Inclusion Criteria:

  • Male or Female patients ≥ 45yrs of age
  • Best corrected Visual acuity 20/30 to 20/320 Snellen equivalent using ETDRS chart measured at 4 meters
  • Signed written informed consent
  • Evidence of Polypoidal choroidal vasculopathy , active in disease activity.
  • Presence of subfoveal, juxtafoveal or extrafoveal active characteristic macular polypoidal lesions on indocyanine green angiography
  • Confirmed to be active in disease activity by fluorescein angiography
  • The total lesion must have the greatest linear dimension less than 5400 microns ( \~9 MPS Disc Areas ) as delineated by indocyanine green angiography
  • Had not been treated in the past
  • Patients willing and able to comply with all study procedures

Exclusion criteria

Exclusion Criteria:

  • Previous history of laser photocoagulation,photodynamic therapy,anti VEGF therapy, submacular surgery in the study eye
  • Have known hypersensitivity to Visudyne® and Lucentis™
  • Previous treatment with external-beam radiation therapy or transpupillary thermotherapy
  • History of vitrectomy
  • Intraocular surgery,yttrium aluminum garnet(YAG) laser\< 1month before day 0
  • Additional eye disease that could compromise visual acuity
  • Ocular inflammation
  • Vitreous hemorrhage
  • Uncontrolled glaucoma
  • Current use or of likely need for systemic medications known to be toxic to the eye.
  • Inability to obtain fluorescein angiography and indocyanine green angiography, due to media opacity, allergy to the dye or lack of venous access
  • Are participating in another clinical study.
  • Disciform scar
  • Mental illness that precludes the patient from giving informed consent
  • Patients who are considered potentially unreliable

\<Control group>

-Age matched patients with cataract without other ocular diseases such as glaucoma, high myopia, ocular ischemic diseases, retinal disease, or with systemic diseases like diabetes mellitus.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    experimental

    Arm 1 : combination treatment of ranibizumab(Lucentis) and verteporfin(Visudyne) injection

    Drug: ranibizumab(Lucentis), verteporfin(Visudyne)

  • Active comparator
    active comparator

    Arm 2 : Treatment of verteporfin(Visudyne)

    Drug: ranibizumab(Lucentis), verteporfin(Visudyne)

  • No intervention
    normal control group

    Arm 3 : normal control group

    Drug: ranibizumab(Lucentis), verteporfin(Visudyne)

Interventions

  • Drugranibizumab(Lucentis), verteporfin(Visudyne)

    ranibizumab(Lucentis) : 0.5mg/0.05ml - intravitreal injection verteporfin (Visudyne) : 15mg (6mg/m2)- intravenous injection

    Also known as: ranibizumab(Lucentis) : 0.5mg/0.05ml, verteportin (Visudyne) : 15mg (6mg/m2)

06

What researchers measure

Primary outcomes

  1. change from baseline in cytokine levels at 1 week, 1 month and 3 month

    1. To compare the baseline level of cytokines in aqueous humor. polypoidal choroidal vasculopathy group(Arm A+Arm B) vs normal control group 2. To compare the change of cytokine level of aqueous humor after combination treatment of intravitreal injection of Lucentis™ and photodynamic therapy versus only photodynamic therapy.(1 week, 1 month, 3 month)

    Time frame: baseline, 1 week, 1 month, 3 month

07

Study locations

1 of 1 sites recruiting
  • Won Ki Lee
    Seoul, South Korea
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01360151
Lead sponsor
Seoul St. Mary's Hospital
First posted
May 25, 2011
Start date
Feb 2011
Primary completion
May 2011 (estimated)
Completion
May 2011 (estimated)
Last update
May 30, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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