PDT Study for Exudative AMD With PCV

March 30, 2011 updated by: Ophthalmic PDT Study Group

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
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
Other Names:
  • photodynamic therapy
EXPERIMENTAL: 2
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
Other Names:
  • photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 month
Factor affecting to change in visual acuity.
Time Frame: 12month
12month
Proportion of eyes with decimal BCVA of 0.5 or more.
Time Frame: 12 month
12 month
Change of findings of polypoidal lesions.
Time Frame: 0-12 month
0-12 month
Change of findings of abnormal network vessels.
Time Frame: 0-12 month
0-12 month
Change in greatest linear dimension (GLD) based on FA.
Time Frame: 0-12 month
0-12 month
PCV lesion size based on ICGA.
Time Frame: 0-12 month
0-12 month
Choroidal neovascularization (CNV) closure based on FA.
Time Frame: 0-12 month
0-12 month
Change in subretinal fluid at the fovea and central retinal thickness based on optical coherence tomography (OCT).
Time Frame: 0-12month
0-12month
Mean number of PDT treatments required during the study period.
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ophthalmic PDT Study Group

Investigators

  • Principal Investigator: Tomohiro Iida, MD, Ophthalmic PDT Study Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

May 30, 2006

First Submitted That Met QC Criteria

May 30, 2006

First Posted (ESTIMATE)

May 31, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2011

Last Update Submitted That Met QC Criteria

March 30, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCV-PDT-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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