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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Matthias Lueke, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01638858
First received: July 2, 2012
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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 Intervention
Age-Related Macular Degeneration
Drug: Lucentis (Ranibizumab)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months


Secondary Outcome Measures:
  • to document changes in best corrected visual acuity measured on 4 meters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    to document changes in best corrected visual acuity measured on 4 meters

  • to document changes in microperimetry [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    to document changes in microperimetry

  • to document changes in optical coherence tomography (OCT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    to document changes in optical coherence tomography (OCT)


Enrollment: 25
Study Start Date: October 2011
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lucentis (Ranibizumab) Drug: Lucentis (Ranibizumab)
Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: July 2, 2012
Last Updated: July 4, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 29, 2014