Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT00331435
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00331435
Study Brief:
Protocol Section:
NCT00331435