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Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration

Primary Purpose

Age-related Macular Degeneration

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Bevacizumab

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

choroidal neovascularization caused by age-related macula degeneration
no previous treatment
a follow-up at least 12 months
a baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart

Exclusion Criteria:

choroidal neovascularization caused by other eye diseases
ocular surgery within the past 3 mouths
history of uveitis
intraocular pressure higher than 25 mmHg, or glaucoma
history of systemic or ocular thromboembolic events.

Sites / Locations

Department of Ophthalmology and Visual Science, Graduate School of Medical Sciences, Kumamoto University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab

Arm Description

Outcomes

Primary Outcome Measures

Visual acuity

Secondary Outcome Measures

Full Information

NCT ID

NCT01032109

First Posted

December 12, 2009

Last Updated

February 25, 2016

Sponsor

Kumamoto University

1. Study Identification

Unique Protocol Identification Number

NCT01032109

Brief Title

Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration

Official Title

Verteporfin Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Neovascular Age-related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kumamoto University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare 12-month results of two single initial treatments-photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab-for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular degeneration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bevacizumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

A single intravitreal injection of 1.25 mg of bevacizumab (0.05 mL of solution prepared from Avastin, 100 mg/4 mL vial) was performed within 2 weeks after PDT treatment.

Primary Outcome Measure Information:

Title

Visual acuity

Time Frame

The comparison between baseline and 12-month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: choroidal neovascularization caused by age-related macula degeneration no previous treatment a follow-up at least 12 months a baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart Exclusion Criteria: choroidal neovascularization caused by other eye diseases ocular surgery within the past 3 mouths history of uveitis intraocular pressure higher than 25 mmHg, or glaucoma history of systemic or ocular thromboembolic events.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Takahiro Kawaji, MD, PhD

Organizational Affiliation

Department of Ophthalmology, Kumamoto University Graduate School & Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Ophthalmology and Visual Science, Graduate School of Medical Sciences, Kumamoto University

City

Kumamoto

ZIP/Postal Code

860-8556

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

20221623

Citation

Hara R, Kawaji T, Inomata Y, Tahara J, Sagara N, Fukushima M, Tanihara H. Photodynamic therapy alone versus combined with intravitreal bevacizumab for neovascular age-related macular degeneration without polypoidal choroidal vasculopathy in Japanese patients. Graefes Arch Clin Exp Ophthalmol. 2010 Jul;248(7):931-6. doi: 10.1007/s00417-010-1343-8. Epub 2010 Mar 10.

Results Reference

derived

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Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration

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