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

July 4, 2014 updated by: Dr. Matthias Lueke, University of Luebeck

A Prospective, Non-randomized, Mono-center, Cohort Study of Evaluate the Effects of 0.5mg Intraocular Ranibizumab (Lucentis)Injections on Retinal Function in Patients With Diabetic Macular Edema (DME) During Twelve Months

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Lübeck, Germany
        • University of Luebeck - Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lucentis (Ranibizumab)
Drug: Lucentis (Ranibizumab)
Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
Time Frame: 12 months
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to document changes in best corrected visual acuity measured on 4 meters
Time Frame: 12 months
to document changes in best corrected visual acuity measured on 4 meters
12 months
to document changes in microperimetry
Time Frame: 12 months
to document changes in microperimetry
12 months
to document changes in optical coherence tomography (OCT)
Time Frame: 12 months
to document changes in optical coherence tomography (OCT)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Investigators

  • Principal Investigator: Salvatore Grisanti, M.D. Prof., University of Luebeck - Department of Ophthalmology: Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 2, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 12, 2012

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 4, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lucentis_DME_ERG
  • 2011-002202-70 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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