PDT Study for Exudative AMD With PCV

Age Related Macular Degeneration Clinical Trial

Official title:

Clinical Research of Photodynamic Therapy for Exudative Age-related Macular Degeneration Accompanied With Polypoidal Choroidal Vasculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331435
• Other study ID #: PCV-PDT-1
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2006
• Last updated: March 30, 2011
• Start date: June 2006
• Est. completion date: January 2010

Study information

• Verified date: March 2011
• Source: Ophthalmic PDT Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: January 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Japan	Nagoya City University Hospital	Aichi
Japan	Nagoya University	Aichi
Japan	Kyushu University	Fukuoka
Japan	Fukushima Medical University School of Medicine	Fukushima
Japan	Gunma University	Gunma
Japan	Kagawa University	Kagawa
Japan	Kyoto University	Kyoto
Japan	Kansai Medical University Hirakata Hospital	Osaka
Japan	Kansai Medical University Takii Hospital	Osaka
Japan	Osaka University	Osaka
Japan	Sapporo City general hospital	Sapporo
Japan	Shiga University of Medical Science	Shiga
Japan	Kyorin University	Tokyo
Japan	Surugadai Nihon University Hospital	Tokyo
Japan	Toho University	Tokyo
Japan	Tokyo University Ohashi Medical Center	Tokyo
Japan	Yamanashi University	Yamanashi

Sponsors (1)

Lead Sponsor	Collaborator
Ophthalmic PDT Study Group

Country where clinical trial is conducted

Japan, 

Outcome

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