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PDT Study for Exudative AMD With PCV

Information source: Ophthalmic PDT Study Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Age Related Macular Degeneration

Intervention: Ocular photodynamic therapy with verteporfin (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: Ophthalmic PDT Study Group

Official(s) and/or principal investigator(s):
Tomohiro Iida, MD, Principal Investigator, Affiliation: Ophthalmic PDT Study Group

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

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.

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.

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Nagoya City University Hospital, Aichi, Japan

Nagoya University, Aichi, Japan

Kyushu University, Fukuoka 812-0054, Japan

Fukushima Medical University School of Medicine, Fukushima 960-1295, Japan

Gunma University, Gunma, Japan

Kagawa University, Kagawa 761-0793, Japan

Kyoto University, Kyoto 606-8507, Japan

Kansai Medical University Hirakata Hospital, Osaka 573-1191, Japan

Kansai Medical University Takii Hospital, Osaka 570-8507, Japan

Osaka University, Osaka 565-0871, Japan

Sapporo City general hospital, Sapporo 060-8604, Japan

Shiga University of Medical Science, Shiga, Japan

Kyorin University, Tokyo 181-8611, Japan

Surugadai Nihon University Hospital, Tokyo 101-8309, Japan

Toho University, Tokyo, Japan

Tokyo University Ohashi Medical Center, Tokyo, Japan

Yamanashi University, Yamanashi, Japan

Additional Information

Starting date: June 2006
Last updated: March 30, 2011

Page last updated: August 23, 2015

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