Clinical trial NCT00331435: PDT Study for Exudative AMD With PCV
Official title: Clinical Research of Photodynamic Therapy for Exudative Age-related Macular Degeneration Accompanied With Polypoidal Choroidal Vasculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age Related Macular Degeneration
Keywords: AMD
PCV
PDT
Lead sponsor: Ophthalmic PDT Study Group
Sponsor class: OTHER
First posted: 2006-05-31
Enrollment: 113
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

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

Primary outcomes:
measure: Proportion of study eyes which best corrected visual acuity (BCVA) improves 2 lines or more or maintains (+/-1 line changes) at 12 months after first treatment, as compared with the visual acuity at baseline period.
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of number of study eyes which BCVA improves 3 lines or more or maintains (+/-1 line), as compared with baseline examination.
timeFrame: 12 month
measure: Factor affecting to change in visual acuity.
timeFrame: 12month
measure: Proportion of eyes with decimal BCVA of 0.5 or more.
timeFrame: 12 month
measure: Change of findings of polypoidal lesions.
timeFrame: 0-12 month
measure: Change of findings of abnormal network vessels.
timeFrame: 0-12 month
measure: Change in greatest linear dimension (GLD) based on FA.
timeFrame: 0-12 month
measure: PCV lesion size based on ICGA.
timeFrame: 0-12 month
measure: Choroidal neovascularization (CNV) closure based on FA.
timeFrame: 0-12 month
measure: Change in subretinal fluid at the fovea and central retinal thickness based on optical coherence tomography (OCT).
timeFrame: 0-12month
measure: Mean number of PDT treatments required during the study period.
timeFrame: 12 month
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Nagoya City University Hospital
city: Aichi
country: Japan
facility: Nagoya University
city: Fukuoka
country: Japan
facility: Kyushu University
city: Fukushima
country: Japan
facility: Fukushima Medical University School of Medicine
city: Gunma
country: Japan
facility: Gunma University
city: Kagawa
country: Japan
facility: Kagawa University
city: Kyoto
country: Japan
facility: Kyoto University
city: Osaka
country: Japan
facility: Osaka University
city: Osaka
country: Japan
facility: Kansai Medical University Takii Hospital
city: Osaka
country: Japan
facility: Kansai Medical University Hirakata Hospital
city: Sapporo
country: Japan
facility: Sapporo City general hospital
city: Shiga
country: Japan
facility: Shiga University of Medical Science
city: Tokyo
country: Japan
facility: Surugadai Nihon University Hospital
city: Tokyo
country: Japan
facility: Kyorin University
city: Tokyo
country: Japan
facility: Toho University
city: Tokyo
country: Japan
facility: Tokyo University Ohashi Medical Center
city: Yamanashi
country: Japan
facility: Yamanashi University
Study officials:
affiliation: Ophthalmic PDT Study Group
name: Tomohiro Iida, MD
role: PRINCIPAL_INVESTIGATOR
References: