PDT Study for Exudative AMD With PCV - Full Text View

Sponsored by:	Ophthalmic PDT Study Group
Information provided by:	Ophthalmic PDT Study Group
ClinicalTrials.gov Identifier:	NCT00331435

Purpose

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).

Condition	Intervention	Phase
Age-Related Macular Degeneration	Procedure: Ocular photodynamic therapy with verteporfin	Phase IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Verteporfin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Research of Photodynamic Therapy for Exudative Age-Related Macular Degeneration Accompanied With Polypoidal Choroidal Vasculopathy

Further study details as provided by Ophthalmic PDT Study Group:

Primary Outcome Measures:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of number of study eyes which BCVA improves 3 lines or more or maintains (+/-1 line), as compared with baseline examination. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Factor affecting to change in visual acuity. [ Time Frame: 12month ] [ Designated as safety issue: No ]
Proportion of eyes with decimal BCVA of 0.5 or more. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Change of findings of polypoidal lesions. [ Time Frame: 0-12 month ] [ Designated as safety issue: No ]
Change of findings of abnormal network vessels. [ Time Frame: 0-12 month ] [ Designated as safety issue: No ]
Change in greatest linear dimension (GLD) based on FA. [ Time Frame: 0-12 month ] [ Designated as safety issue: No ]
PCV lesion size based on ICGA. [ Time Frame: 0-12 month ] [ Designated as safety issue: No ]
Choroidal neovascularization (CNV) closure based on FA. [ Time Frame: 0-12 month ] [ Designated as safety issue: No ]
Change in subretinal fluid at the fovea and central retinal thickness based on optical coherence tomography (OCT). [ Time Frame: 0-12month ] [ Designated as safety issue: No ]
Mean number of PDT treatments required during the study period. [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Enrollment:	113
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator FA-guided PDT	Procedure: Ocular photodynamic therapy with verteporfin Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds
2: Experimental ICG-guided PDT	Procedure: Ocular photodynamic therapy with verteporfin Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds

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

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331435

Locations

Japan
Fukushima Medical University School of Medicine
Fukushima, Japan, 960-1295
Sapporo City general hospital
Sapporo, Japan, 060-8604
Surugadai Nihon University Hospital
Tokyo, Japan, 101-8309
Kyorin University
Tokyo, Japan, 181-8611
Osaka University
Osaka, Japan, 565-0871
Kagawa University
Kagawa, Japan, 761-0793
Kansai Medical University Hirakata Hospital
Osaka, Japan, 573-1191
Kansai Medical University Takii Hospital
Osaka, Japan, 570-8507
Shiga University of Medical Science
Shiga, Japan
Kyoto University
Kyoto, Japan, 606-8507
Gunma University
Gunma, Japan
Tokyo University Ohashi Medical Center
Tokyo, Japan
Toho University
Tokyo, Japan
Nagoya City University Hospital
Aichi, Japan
Nagoya University
Aichi, Japan
Yamanashi University
Yamanashi, Japan
Kyushu University
Fukuoka, Japan, 812-0054

Sponsors and Collaborators

Ophthalmic PDT Study Group

Investigators

Principal Investigator:

Tomohiro Iida, MD

Ophthalmic PDT Study Group

More Information

Responsible Party:	Ophthalmic PDT study group ( Tomohiro Iida )
Study ID Numbers:	PCV-PDT-1
Study First Received:	May 30, 2006
Last Updated:	January 19, 2008
ClinicalTrials.gov Identifier:	NCT00331435
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ophthalmic PDT Study Group:

AMD
PCV
PDT

Study placed in the following topic categories:

Eye Diseases
Verteporfin
Retinal Degeneration

Macular Degeneration
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009