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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Seoul St. Mary's Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Seoul St. Mary's Hospital

ClinicalTrials.gov Identifier:

NCT01360151

First received: April 12, 2011

Last updated: May 27, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 12, 2011
Last Updated Date	May 27, 2011
Start Date ^ICMJE	February 2011
Estimated Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 27, 2011)	change from baseline in cytokine levels at 1 week, 1 month and 3 month [ Time Frame: baseline, 1 week, 1 month, 3 month ] [ Designated as safety issue: Yes ] 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)
Original Primary Outcome Measures ^ICMJE (submitted: May 24, 2011)	change from baseline in Cytokine levels at 1 week, 1 month and 3 month [ Time Frame: baseline, 1 week, 1 month, 3 month ] [ Designated as safety issue: Yes ] To compare the baseline level of cytokines in aqueous humor. PCV group(Arm A+Arm B) vs normal control group To compare the change of cytokine level of aqueous humor from baseline (1 week, 1 month, 3 month) after combination treatment of intravitreal injection of Lucentis™ and PDT versus PDT monotherapy.
Change History	Complete list of historical versions of study NCT01360151 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Aqueous Humor Level of Cytokines in Polypoidal Choroidal Vasculopathy and Change of Cytokines After Photodynamic Therapy
Official Title ^ICMJE	Not Provided
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Polypoidal Choroidal Vasculopathy
Intervention ^ICMJE	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)
Study Arm (s)	Experimental: experimental Arm 1 : combination treatment of ranibizumab(Lucentis) and verteporfin(Visudyne) injection Intervention: Drug: ranibizumab(Lucentis), verteporfin(Visudyne) Active Comparator: active comparator Arm 2 : Treatment of verteporfin(Visudyne) Intervention: Drug: ranibizumab(Lucentis), verteporfin(Visudyne) No Intervention: normal control group Arm 3 : normal control group Intervention: Drug: ranibizumab(Lucentis), verteporfin(Visudyne)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	16
Estimated Completion Date	May 2011
Estimated Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	<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.
Gender	Both
Ages	45 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01360151
Other Study ID Numbers ^ICMJE	1-Lee
Has Data Monitoring Committee	Yes
Responsible Party	Ophthalmology, Professor, Seoul St. Mary's Hospital, Catholic University of Korea, School of Medicine
Study Sponsor ^ICMJE	Seoul St. Mary's Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul St. Mary's Hospital
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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