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

Not Applicable

• Conditions: Polypoidal Choroidal Vasculopathy
• Interventions: Drug: ranibizumab(Lucentis), verteporfin(Visudyne)

• Registration Number: NCT01360151
• Lead Sponsor: Seoul St. Mary's Hospital

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 Timeline

• Study Start: 2011-02
• Status Verified: 2011-04
• Study First Submitted: 2011-04-12
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Last Update Submitted: 2011-05-27
• Last Update Posted: 2011-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	ranibizumab(Lucentis), verteporfin(Visudyne)	Arm 1 : combination treatment of ranibizumab(Lucentis) and verteporfin(Visudyne) injection
active comparator	ranibizumab(Lucentis), verteporfin(Visudyne)	Arm 2 : Treatment of verteporfin(Visudyne)
normal control group	ranibizumab(Lucentis), verteporfin(Visudyne)	Arm 3 : normal control group

Primary Outcome Measures

Name	Time	Method
change from baseline in cytokine levels at 1 week, 1 month and 3 month	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)

Trial Locations

Locations (1)

Won Ki Lee; 🇰🇷 Seoul, Korea, Republic of