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

Polypoidal Choroidal Vasculopathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01360151
• Other study ID #: 1-Lee
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2011
• Last updated: May 27, 2011
• Start date: February 2011
• Est. completion date: May 2011

Study information

• Verified date: April 2011
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

<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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Won Ki Lee	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline, 1 week, 1 month, 3 month	Yes