PDT Study for Exudative AMD With PCV

Phase 4

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Procedure: Ocular photodynamic therapy with verteporfin

• Registration Number: NCT00331435
• Lead Sponsor: Ophthalmic PDT Study Group

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.

Study Timeline

• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-05-31
• Study Start: 2006-06
• Primary Completion: 2009-01
• Study Completion: 2010-01
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-30
• Last Update Posted: 2011-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ocular photodynamic therapy with verteporfin	FA-guided PDT
2	Ocular photodynamic therapy with verteporfin	ICG-guided PDT

Primary Outcome Measures

Name	Time	Method
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.	12 months

Secondary Outcome Measures

Name	Time	Method
Change of findings of abnormal network vessels.	0-12 month
Proportion of number of study eyes which BCVA improves 3 lines or more or maintains (+/-1 line), as compared with baseline examination.	12 month
Change of findings of polypoidal lesions.	0-12 month
Choroidal neovascularization (CNV) closure based on FA.	0-12 month
Factor affecting to change in visual acuity.	12month
PCV lesion size based on ICGA.	0-12 month
Mean number of PDT treatments required during the study period.	12 month
Change in subretinal fluid at the fovea and central retinal thickness based on optical coherence tomography (OCT).	0-12month
Proportion of eyes with decimal BCVA of 0.5 or more.	12 month
Change in greatest linear dimension (GLD) based on FA.	0-12 month

Trial Locations

Locations (17)

Fukushima Medical University School of Medicine; 🇯🇵 Fukushima, Japan

Kyoto University; 🇯🇵 Kyoto, Japan

Nagoya University; 🇯🇵 Aichi, Japan

Gunma University; 🇯🇵 Gunma, Japan

Toho University; 🇯🇵 Tokyo, Japan

Kansai Medical University Takii Hospital; 🇯🇵 Osaka, Japan

Shiga University of Medical Science; 🇯🇵 Shiga, Japan

Kagawa University; 🇯🇵 Kagawa, Japan

Yamanashi University; 🇯🇵 Yamanashi, Japan

Osaka University; 🇯🇵 Osaka, Japan

Nagoya City University Hospital; 🇯🇵 Aichi, Japan

Kyushu University; 🇯🇵 Fukuoka, Japan

Sapporo City general hospital; 🇯🇵 Sapporo, Japan

Surugadai Nihon University Hospital; 🇯🇵 Tokyo, Japan

Tokyo University Ohashi Medical Center; 🇯🇵 Tokyo, Japan

Kansai Medical University Hirakata Hospital; 🇯🇵 Osaka, Japan

Kyorin University; 🇯🇵 Tokyo, Japan