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Completed

NCT Number: NCT00331435

PDT Study for Exudative AMD With PCV

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).

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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nagoya City University Hospital, Aichi, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocular photodynamic therapy with verteporfin

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Factor affecting to change in visual acuity.

    Time frame: 12month

  3. Proportion of eyes with decimal BCVA of 0.5 or more.

    Time frame: 12 month

  4. Change of findings of polypoidal lesions.

    Time frame: 0-12 month

  5. Change of findings of abnormal network vessels.

    Time frame: 0-12 month

  6. Change in greatest linear dimension (GLD) based on FA.

    Time frame: 0-12 month

  7. PCV lesion size based on ICGA.

    Time frame: 0-12 month

  8. Choroidal neovascularization (CNV) closure based on FA.

    Time frame: 0-12 month

  9. Change in subretinal fluid at the fovea and central retinal thickness based on optical coherence tomography (OCT).

    Time frame: 0-12month

  10. Mean number of PDT treatments required during the study period.

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

Ophthalmic PDT Study Group

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
May 31, 2006
Registry last updated
Mar 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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