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

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ranibizumab(Lucentis), verteporfin(Visudyne)
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Polypoidal Choroidal Vasculopathy focused on measuring VEGF (Vascular endothelial growth factor)

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

<Polypoidal choroidal vasculopathy group>

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:

  • 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.

Sites / Locations

  • Won Ki LeeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

experimental

active comparator

normal control group

Arm Description

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

Arm 2 : Treatment of verteporfin(Visudyne)

Arm 3 : normal control group

Outcomes

Primary Outcome Measures

change from baseline in cytokine levels at 1 week, 1 month and 3 month
To compare the baseline level of cytokines in aqueous humor. polypoidal choroidal vasculopathy group(Arm A+Arm B) vs normal control group 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)

Secondary Outcome Measures

Full Information

First Posted
April 12, 2011
Last Updated
May 27, 2011
Sponsor
Seoul St. Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01360151
Brief Title
Aqueous Humor Level of Cytokines in Polypoidal Choroidal Vasculopathy and Change of Cytokines After Photodynamic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul St. Mary's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypoidal Choroidal Vasculopathy
Keywords
VEGF (Vascular endothelial growth factor)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
Arm 1 : combination treatment of ranibizumab(Lucentis) and verteporfin(Visudyne) injection
Arm Title
active comparator
Arm Type
Active Comparator
Arm Description
Arm 2 : Treatment of verteporfin(Visudyne)
Arm Title
normal control group
Arm Type
No Intervention
Arm Description
Arm 3 : normal control group
Intervention Type
Drug
Intervention Name(s)
ranibizumab(Lucentis), verteporfin(Visudyne)
Other Intervention Name(s)
ranibizumab(Lucentis) : 0.5mg/0.05ml, verteportin (Visudyne) : 15mg (6mg/m2)
Intervention Description
ranibizumab(Lucentis) : 0.5mg/0.05ml - intravitreal injection verteporfin (Visudyne) : 15mg (6mg/m2)- intravenous injection
Primary Outcome Measure Information:
Title
change from baseline in cytokine levels at 1 week, 1 month and 3 month
Description
To compare the baseline level of cytokines in aqueous humor. polypoidal choroidal vasculopathy group(Arm A+Arm B) vs normal control group 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
<Polypoidal choroidal vasculopathy group> 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: 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.
Facility Information:
Facility Name
Won Ki Lee
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Ki Lee, MD, PhD
Phone
82-2-10-3265-1262
Email
wklee@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Mee Yon Lee, MD
Phone
82-10-3230-1863
Email
deenie@daum.net

12. IPD Sharing Statement

Learn more about this trial

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

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