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PDT Study for Exudative AMD With PCV

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Ocular photodynamic therapy with verteporfin
Sponsored by
Ophthalmic PDT Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring AMD, PCV, PDT

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

FA-guided PDT

ICG-guided PDT

Outcomes

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.

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.
Factor affecting to change in visual acuity.
Proportion of eyes with decimal BCVA of 0.5 or more.
Change of findings of polypoidal lesions.
Change of findings of abnormal network vessels.
Change in greatest linear dimension (GLD) based on FA.
PCV lesion size based on ICGA.
Choroidal neovascularization (CNV) closure based on FA.
Change in subretinal fluid at the fovea and central retinal thickness based on optical coherence tomography (OCT).
Mean number of PDT treatments required during the study period.

Full Information

First Posted
May 30, 2006
Last Updated
March 30, 2011
Sponsor
Ophthalmic PDT Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00331435
Brief Title
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

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ophthalmic PDT Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
AMD, PCV, PDT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
FA-guided PDT
Arm Title
2
Arm Type
Experimental
Arm Description
ICG-guided PDT
Intervention Type
Procedure
Intervention Name(s)
Ocular photodynamic therapy with verteporfin
Other Intervention Name(s)
photodynamic therapy
Intervention Description
Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Factor affecting to change in visual acuity.
Time Frame
12month
Title
Proportion of eyes with decimal BCVA of 0.5 or more.
Time Frame
12 month
Title
Change of findings of polypoidal lesions.
Time Frame
0-12 month
Title
Change of findings of abnormal network vessels.
Time Frame
0-12 month
Title
Change in greatest linear dimension (GLD) based on FA.
Time Frame
0-12 month
Title
PCV lesion size based on ICGA.
Time Frame
0-12 month
Title
Choroidal neovascularization (CNV) closure based on FA.
Time Frame
0-12 month
Title
Change in subretinal fluid at the fovea and central retinal thickness based on optical coherence tomography (OCT).
Time Frame
0-12month
Title
Mean number of PDT treatments required during the study period.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomohiro Iida, MD
Organizational Affiliation
Ophthalmic PDT Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nagoya City University Hospital
City
Aichi
Country
Japan
Facility Name
Nagoya University
City
Aichi
Country
Japan
Facility Name
Kyushu University
City
Fukuoka
ZIP/Postal Code
812-0054
Country
Japan
Facility Name
Fukushima Medical University School of Medicine
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Gunma University
City
Gunma
Country
Japan
Facility Name
Kagawa University
City
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kyoto University
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Osaka University
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Kansai Medical University Takii Hospital
City
Osaka
ZIP/Postal Code
570-8507
Country
Japan
Facility Name
Kansai Medical University Hirakata Hospital
City
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Sapporo City general hospital
City
Sapporo
ZIP/Postal Code
060-8604
Country
Japan
Facility Name
Shiga University of Medical Science
City
Shiga
Country
Japan
Facility Name
Surugadai Nihon University Hospital
City
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
Facility Name
Kyorin University
City
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Toho University
City
Tokyo
Country
Japan
Facility Name
Tokyo University Ohashi Medical Center
City
Tokyo
Country
Japan
Facility Name
Yamanashi University
City
Yamanashi
Country
Japan

12. IPD Sharing Statement

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PDT Study for Exudative AMD With PCV

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