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

NCT ID: NCT01360151

Last Updated: 2011-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Polypoidal Choroidal Vasculopathy

Keywords

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VEGF (Vascular endothelial growth factor)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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experimental

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

Group Type EXPERIMENTAL

ranibizumab(Lucentis), verteporfin(Visudyne)

Intervention Type DRUG

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

active comparator

Arm 2 : Treatment of verteporfin(Visudyne)

Group Type ACTIVE_COMPARATOR

ranibizumab(Lucentis), verteporfin(Visudyne)

Intervention Type DRUG

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

normal control group

Arm 3 : normal control group

Group Type NO_INTERVENTION

ranibizumab(Lucentis), verteporfin(Visudyne)

Intervention Type DRUG

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

Interventions

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ranibizumab(Lucentis), verteporfin(Visudyne)

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

Intervention Type DRUG

Other Intervention Names

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ranibizumab(Lucentis) : 0.5mg/0.05ml verteportin (Visudyne) : 15mg (6mg/m2)

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Professor, Seoul St. Mary's Hospital, Catholic University of Korea, School of Medicine

Locations

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Won Ki Lee

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Won Ki Lee, MD, PhD

Role: primary

Mee Yon Lee, MD

Role: backup

Other Identifiers

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1-Lee

Identifier Type: -

Identifier Source: org_study_id