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Age Related Macular DegenerationPhase 4NCT00331435

PDT Study for Exudative AMD With PCV

A Phase 4 study testing Ocular photodynamic therapy with verteporfin in people with Age Related Macular Degeneration, run by Ophthalmic PDT Study Group at 17 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age Related Macular Degeneration
What is being tested?
Ocular photodynamic therapy with verteporfin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
17 sitesJapan
Study dates
Jun 2006to Jan 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Japan17 sites

  • Nagoya City University Hospital

    Aichi

  • Nagoya University

    Aichi

  • Kyushu University

    Fukuoka, 812-0054

  • Fukushima Medical University School of Medicine

    Fukushima, 960-1295

  • Gunma University

    Gunma

  • Kagawa University

    Kagawa, 761-0793

  • Kyoto University

    Kyoto, 606-8507

  • Osaka University

    Osaka, 565-0871

  • Kansai Medical University Takii Hospital

    Osaka, 570-8507

  • Kansai Medical University Hirakata Hospital

    Osaka, 573-1191

  • Sapporo City general hospital

    Sapporo, 060-8604

  • Shiga University of Medical Science

    Shiga

  • Surugadai Nihon University Hospital

    Tokyo, 101-8309

  • Kyorin University

    Tokyo, 181-8611

  • Toho University

    Tokyo

  • Tokyo University Ohashi Medical Center

    Tokyo

  • Yamanashi University

    Yamanashi

Other trials in Japan

About this study

Official title: 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).

Read the 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.

Being tested
Ocular photodynamic therapy with verteporfin
Keywords
AMD, PCV, PDT
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ocular photodynamic therapy with verteporfinProcedure or surgery

    Also called photodynamic therapy

    Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds

Study groups in NCT00331435
Study groupRoleWhat they receive
1Active comparatorFA-guided PDT
Receives: Procedure: Ocular photodynamic therapy with verteporfin
2ExperimentalICG-guided PDT
Receives: Procedure: Ocular photodynamic therapy with verteporfin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (10)

  1. Proportion of number of study eyes which BCVA improves 3 lines or more or maintains (+/-1 line), as compared with baseline examination.

    Measured: 12 month

  2. Factor affecting to change in visual acuity.

    Measured: 12month

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

    Measured: 12 month

  4. Change of findings of polypoidal lesions.

    Measured: 0-12 month

  5. Change of findings of abnormal network vessels.

    Measured: 0-12 month

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

    Measured: 0-12 month

  7. PCV lesion size based on ICGA.

    Measured: 0-12 month

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

    Measured: 0-12 month

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

    Measured: 0-12month

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

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionJan 2009
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00331435
Sponsor's protocol ID
PCV-PDT-1
Status last verified
Mar 2011
First submitted
30 May 2006
Last updated
31 Mar 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ocular photodynamic therapy with verteporfin in people with Age Related Macular Degeneration, run by Ophthalmic PDT Study Group at 17 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00331435.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2011; AzTrials last refreshed its copy on 27 Oct 2026.

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