Ranibizumab Treatment for Age-Related Macular Degeneretion

NCT ID: NCT02158624

Last Updated: 2014-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-12-31

Brief Summary

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To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients.

Detailed Description

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Conditions

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Visual Disorder Due to Age-related Macula Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ranibizumab

Group Type EXPERIMENTAL

Intravitreal Lucentis 0.5mg

Intervention Type DRUG

Interventions

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Intravitreal Lucentis 0.5mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Active primary or recurrent subfoveal choroidal neovascularization lesion due to AMD
* Subjects of either gender age 50 years or older
* Visual acuity better than 0.05 decimal( 20/400 Snellen)
* Signed informed consent form

Exclusion Criteria

* Prior treatment for neovascular AMD in the study eye, for example, PDT or anti-VEGF therapy
* Patients whose lesion site evaluated by FA examination is more than 12DA in subject eye
* Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye
* Patients with a history of intraocular surgical operation(including cataract)within 3 months in subject eye
* Patients with serious allergic history to such as fluorescein, indocyanine green, iodophors
* The pregnant or lactating woman
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Occupational and Environmental Health

OTHER

Sponsor Role collaborator

Kurume University

OTHER

Sponsor Role collaborator

Fukuoka University

OTHER

Sponsor Role collaborator

Clinical Research Support Center Kyush

OTHER

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

Kyushu University

OTHER

Sponsor Role lead

Responsible Party

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Yuji Oshima

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Ophthalmology, Kyushu University Hospital

Maidashi, Higashiku, Fukuoka-city, Fukuoka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Tatsuro Ishibashi, MD. PhD

Role: CONTACT

+81-92-642-5648

Yuji Oshima, MD. PhD

Role: CONTACT

+81-92-642-5648

Facility Contacts

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Yuji Oshima, MD. PhD

Role: primary

+81-92-642-5648

Other Identifiers

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13-E-09

Identifier Type: -

Identifier Source: org_study_id

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