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

May 27, 2011 updated by: Seoul St. Mary's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

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

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

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

<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.

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: experimental
Arm 1 : combination treatment of ranibizumab(Lucentis) and verteporfin(Visudyne) injection
Drug: ranibizumab(Lucentis), verteporfin(Visudyne)
ranibizumab(Lucentis) : 0.5mg/0.05ml - intravitreal injection verteporfin (Visudyne) : 15mg (6mg/m2)- intravenous injection
Other Names:
  • ranibizumab(Lucentis) : 0.5mg/0.05ml
  • verteportin (Visudyne) : 15mg (6mg/m2)
ACTIVE_COMPARATOR: active comparator
Arm 2 : Treatment of verteporfin(Visudyne)
Drug: ranibizumab(Lucentis), verteporfin(Visudyne)
ranibizumab(Lucentis) : 0.5mg/0.05ml - intravitreal injection verteporfin (Visudyne) : 15mg (6mg/m2)- intravenous injection
Other Names:
  • ranibizumab(Lucentis) : 0.5mg/0.05ml
  • verteportin (Visudyne) : 15mg (6mg/m2)
NO_INTERVENTION: normal control group
Arm 3 : normal control group
Drug: ranibizumab(Lucentis), verteporfin(Visudyne)
ranibizumab(Lucentis) : 0.5mg/0.05ml - intravitreal injection verteporfin (Visudyne) : 15mg (6mg/m2)- intravenous injection
Other Names:
  • ranibizumab(Lucentis) : 0.5mg/0.05ml
  • verteportin (Visudyne) : 15mg (6mg/m2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in cytokine levels at 1 week, 1 month and 3 month
Time Frame: baseline, 1 week, 1 month, 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)
baseline, 1 week, 1 month, 3 month

Collaborators and Investigators

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

Sponsor

Seoul St. Mary's Hospital

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

February 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2011

Study Completion (ANTICIPATED)

May 1, 2011

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (ESTIMATE)

May 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 30, 2011

Last Update Submitted That Met QC Criteria

May 27, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Lee

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.

Clinical Trials on Polypoidal Choroidal Vasculopathy

Clinical Trials on ranibizumab(Lucentis), verteporfin(Visudyne)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe