Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)

NCT ID: NCT01638858

Last Updated: 2014-07-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Brief Summary

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In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.

Detailed Description

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Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Lucentis (Ranibizumab)

Group Type EXPERIMENTAL

Lucentis (Ranibizumab)

Intervention Type DRUG

Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

Interventions

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Lucentis (Ranibizumab)

Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. diabetic macular edema with center involvement in at least one eye
2. patients with a central retinal thickness
3. patients with a BCVA of 78-24 EDTRS letters
4. decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
5. Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening

Exclusion Criteria

1. history or evidence of severe cardiac disease
2. clinical or medical history uncontrolled hypertension or diabetes
3. of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
4. ventricular tachyarrhythmias requiring ongoing treatment
5. history or evidence clinically significant peripheral vascular disease, such a intermittent claudication or prior amputation
6. clinically significant impaired renal or hepatic function
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Dr. Matthias Lueke

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salvatore Grisanti, M.D. Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Luebeck - Department of Ophthalmology: Germany

Locations

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University of Luebeck - Department of Ophthalmology

Lübeck, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.uksh.de/Augenklinik_Lübeck/index.html

Link Text: University of Lübeck - Department of Ophthalmology - Germany

Other Identifiers

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2011-002202-70

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Lucentis_DME_ERG

Identifier Type: -

Identifier Source: org_study_id

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