PDT Study for Exudative AMD With PCV

Ophthalmic PDT Study Group

Status and phase

Completed

Phase 4

Conditions

Age Related Macular Degeneration

Treatments

Procedure: Ocular photodynamic therapy with verteporfin

Study type

Interventional

Funder types

Other

Identifiers

NCT00331435

PCV-PDT-1

Details and patient eligibility

About

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 angiography (FA) guided PDT for exudative age-related macular degeneration (AMD) accompanied with polypoidal choroidal vasculopathy (PCV).

Full 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 lesions or abnormal network vessels. In clinical practice, PDT based on ICGA (ICGA guided PDT) has and is being conducted for the treatment of AMD with PCV. However, there are no reports on the outcomes of prospective research of PDT for PCV in Japanese patients. Furthermore, there are no reports comparing FA guided PDT and ICGA guided PDT.

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.

Enrollment

113 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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