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PDT Study for Exudative AMD With PCV

This study has been completed.
Sponsor:
Information provided by:
Ophthalmic PDT Study Group
ClinicalTrials.gov Identifier:
NCT00331435
First received: May 30, 2006
Last updated: March 30, 2011
Last verified: March 2011
History of Changes

May 30, 2006
March 30, 2011
June 2006
January 2009   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00331435 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in the BCVA as compared with baseline examination.
  • 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.
  • Frequency of adverse effects on study eyes.
Not Provided
Not Provided
 
PDT Study for Exudative AMD With PCV
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).

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Age Related Macular Degeneration
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 Name: photodynamic therapy
  • Active Comparator: 1
    FA-guided PDT
    Intervention: Procedure: Ocular photodynamic therapy with verteporfin
  • Experimental: 2
    ICG-guided PDT
    Intervention: Procedure: Ocular photodynamic therapy with verteporfin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
January 2010
January 2009   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00331435
PCV-PDT-1
Yes
Tomohiro Iida, Ophthalmic PDT study group
Ophthalmic PDT Study Group
Not Provided
Principal Investigator: Tomohiro Iida, MD Ophthalmic PDT Study Group
Ophthalmic PDT Study Group
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP