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
  Purpose

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.


Condition Intervention
Polypoidal Choroidal Vasculopathy
Drug: ranibizumab(Lucentis), verteporfin(Visudyne)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • 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 ]
    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)


Estimated Enrollment: 16
Study Start Date: February 2011
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

<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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01360151

Locations
Korea, Republic of
Won Ki Lee Recruiting
Seoul, Korea, Republic of
Contact: Won Ki Lee, MD, PhD    82-2-10-3265-1262    wklee@catholic.ac.kr   
Contact: Mee Yon Lee, MD    82-10-3230-1863    deenie@daum.net   
Sponsors and Collaborators
Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Ophthalmology, Professor, Seoul St. Mary's Hospital, Catholic University of Korea, School of Medicine
ClinicalTrials.gov Identifier: NCT01360151     History of Changes
Other Study ID Numbers: 1-Lee
Study First Received: April 12, 2011
Last Updated: May 27, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul St. Mary's Hospital:
VEGF (Vascular endothelial growth factor)

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 27, 2014