PDT Study for Exudative AMD With PCV

NCT00331435 | Completed Phase 4 DMC

• 1 other identifier: PCV-PDT-1
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 17

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).

Conditions

Age Related Macular Degeneration

Keywords

AMD; PCV; PDT

Outcome Measures

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.

  12 months

Secondary Outcomes (10)

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

  12 month

• Factor affecting to change in visual acuity.

  12month

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

  12 month

• Change of findings of polypoidal lesions.

  0-12 month

• Change of findings of abnormal network vessels.

  0-12 month

Study Arms (2)

1

ACTIVE COMPARATOR

FA-guided PDT

Procedure: Ocular photodynamic therapy with verteporfin

2

EXPERIMENTAL

ICG-guided PDT

Procedure: Ocular photodynamic therapy with verteporfin

Interventions

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

Also known as: photodynamic therapy

1; 2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ophthalmic PDT Study Group: lead

Study Sites (17)

Nagoya City University Hospital

Aichi, Japan

Location

Nagoya University

Aichi, Japan

Location

Kyushu University

Fukuoka, 812-0054, Japan

Location

Fukushima Medical University School of Medicine

Fukushima, 960-1295, Japan

Location

Gunma University

Gunma, Japan

Location

Kagawa University

Kagawa, 761-0793, Japan

Location

Kyoto University

Kyoto, 606-8507, Japan

Location

Osaka University

Osaka, 565-0871, Japan

Location

Kansai Medical University Takii Hospital

Osaka, 570-8507, Japan

Location

Kansai Medical University Hirakata Hospital

Osaka, 573-1191, Japan

Location

Sapporo City general hospital

Sapporo, 060-8604, Japan

Location

Shiga University of Medical Science

Shiga, Japan

Location

Surugadai Nihon University Hospital

Tokyo, 101-8309, Japan

Location

Kyorin University

Tokyo, 181-8611, Japan

Location

Toho University

Tokyo, Japan

Location

Tokyo University Ohashi Medical Center

Tokyo, Japan

Location

Yamanashi University

Yamanashi, Japan

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Verteporfin; Photochemotherapy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Tomohiro Iida, MD

  Ophthalmic PDT Study Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: May 31, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 31, 2011

Record last verified: 2011-03

Locations

JP (17)