Status:
COMPLETED
PDT Study for Exudative AMD With PCV
Lead Sponsor:
Ophthalmic PDT Study Group
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate and conduct an exploratory comparison of the efficacy and safety of indocyanine green angiography (ICGA) guided photodynamic therapy (PDT) and fluorescein angi...
Detailed Description
PDT with verteporfin has been proven beneficial for patients with AMD. The laser spot size is decided based on FA finding (FA guided PDT). ICGA is needed to detect PCV lesions, such as polypoidal lesi...
Eligibility Criteria
Inclusion
- Japanese patients aged 50 years old or older
- 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
- Patients who have RPE tear, vitelliform retinal dystrophy, and central Serous Chorioretinopathy.
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00331435
Start Date
June 1 2006
End Date
January 1 2010
Last Update
March 31 2011
Active Locations (17)
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1
Nagoya City University Hospital
Aichi, Japan
2
Nagoya University
Aichi, Japan
3
Kyushu University
Fukuoka, Japan, 812-0054
4
Fukushima Medical University School of Medicine
Fukushima, Japan, 960-1295