Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
113 participants
INTERVENTIONAL
2006-06-30
2010-01-31
Brief Summary
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Detailed Description
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We propose to conduct this clinical research in order to investigate the efficacy and safety of PDT for PCV in Japanese patients, and to compare results of FA guided PDT and ICGA guided PDT.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
FA-guided PDT
Ocular photodynamic therapy with verteporfin
Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds
2
ICG-guided PDT
Ocular photodynamic therapy with verteporfin
Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds
Interventions
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Ocular photodynamic therapy with verteporfin
Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Exudative AMD with subfoveal PCV
* Eyes with PCV meets the definite criteria of PCV issued from Japanese study group of Polypoidal Choroidal Vasculopathy
* PCV lesion with subfoveal hemorrhage or exudation
* Lesion size (GLD) of less than 12 MPS Disc area measured by FA and IA.
* Decimal BCVA of 0.1-0.5 at baseline period.
Exclusion Criteria
* Patients who have other ocular disease with irreversible VA
* Study eyes unable to be taken fundus photos of CNV
* Study eyes received surgery operation within 2 months of the participation to this study or ND:YAG operation within one month
* Pathological myopia
* PCV with cleary identified subsensory retinal CNV (on the RPE) at the baseline examination
* Study eyes which have received any treatments for CNV, such as PDT, transpupillary thermotherapy, laser photocoagulation, and so on.
* Patients who have any physical problem for using angiography or PDT (such as systemic debility, significant diabetes mellitus, significant heart disease, and so on)
* Medical history of porphyria, porphyrin sensitivity, or hypersensitivity to sunlight or bright light.
* Patients with medical history of hypersensitivity to ingredients of Visudyne
* Patients with medical history of hypersensitivity to ingredients of fluorescein or indocyanine green injection
* Patients with hypersensitivity to iodine
* Patients judged inappropriate for this study by the investigator
50 Years
ALL
No
Sponsors
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Ophthalmic PDT Study Group
OTHER
Responsible Party
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Ophthalmic PDT study group
Principal Investigators
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Tomohiro Iida, MD
Role: PRINCIPAL_INVESTIGATOR
Ophthalmic PDT Study Group
Locations
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Nagoya City University Hospital
Aichi, , Japan
Nagoya University
Aichi, , Japan
Kyushu University
Fukuoka, , Japan
Fukushima Medical University School of Medicine
Fukushima, , Japan
Gunma University
Gunma, , Japan
Kagawa University
Kagawa, , Japan
Kyoto University
Kyoto, , Japan
Osaka University
Osaka, , Japan
Kansai Medical University Takii Hospital
Osaka, , Japan
Kansai Medical University Hirakata Hospital
Osaka, , Japan
Sapporo City general hospital
Sapporo, , Japan
Shiga University of Medical Science
Shiga, , Japan
Surugadai Nihon University Hospital
Tokyo, , Japan
Kyorin University
Tokyo, , Japan
Toho University
Tokyo, , Japan
Tokyo University Ohashi Medical Center
Tokyo, , Japan
Yamanashi University
Yamanashi, , Japan
Countries
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Other Identifiers
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PCV-PDT-1
Identifier Type: -
Identifier Source: org_study_id