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
Recruitment status was Recruiting
Sponsor:
Seoul St. Mary's Hospital
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
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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 ]
- 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)
| 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:
|
|
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:
|
|
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:
|
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
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:
|
Verteporfin Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs |
Pharmacologic Actions Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013