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

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ClinicalTrials.gov Identifier: NCT01638858
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Age-Related Macular Degeneration Drug: Lucentis (Ranibizumab)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : October 2011
Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. to document changes in microperimetry [ Time Frame: 12 months ]
    to document changes in microperimetry

  3. to document changes in optical coherence tomography (OCT) [ Time Frame: 12 months ]
    to document changes in optical coherence tomography (OCT)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638858


Locations
Germany
University of Luebeck - Department of Ophthalmology
Lübeck, Germany
Sponsors and Collaborators
University of Luebeck
Investigators
Principal Investigator: Salvatore Grisanti, M.D. Prof. University of Luebeck - Department of Ophthalmology: Germany
More Information

Additional Information:
Responsible Party: Dr. Matthias Lueke, Principal Investigator, University of Luebeck
ClinicalTrials.gov Identifier: NCT01638858     History of Changes
Other Study ID Numbers: Lucentis_DME_ERG
2011-002202-70 ( EudraCT Number )
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents