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

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Lucentis (Ranibizumab)
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Age-Related Macular Degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Luebeck - Department of Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lucentis (Ranibizumab)

Arm Description

Outcomes

Primary Outcome Measures

Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 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

to document changes in best corrected visual acuity measured on 4 meters
to document changes in best corrected visual acuity measured on 4 meters
to document changes in microperimetry
to document changes in microperimetry
to document changes in optical coherence tomography (OCT)
to document changes in optical coherence tomography (OCT)

Full Information

First Posted
July 2, 2012
Last Updated
July 4, 2014
Sponsor
University of Luebeck
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1. Study Identification

Unique Protocol Identification Number
NCT01638858
Brief Title
Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lucentis (Ranibizumab)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lucentis (Ranibizumab)
Intervention Description
Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry
Primary Outcome Measure Information:
Title
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
Description
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
to document changes in best corrected visual acuity measured on 4 meters
Description
to document changes in best corrected visual acuity measured on 4 meters
Time Frame
12 months
Title
to document changes in microperimetry
Description
to document changes in microperimetry
Time Frame
12 months
Title
to document changes in optical coherence tomography (OCT)
Description
to document changes in optical coherence tomography (OCT)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diabetic macular edema with center involvement in at least one eye patients with a central retinal thickness patients with a BCVA of 78-24 EDTRS letters decrease in vision is due to DME and not due to other causes, in the opinion of the investigator Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening Exclusion Criteria: history or evidence of severe cardiac disease clinical or medical history uncontrolled hypertension or diabetes of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months ventricular tachyarrhythmias requiring ongoing treatment history or evidence clinically significant peripheral vascular disease, such a intermittent claudication or prior amputation clinically significant impaired renal or hepatic function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Grisanti, M.D. Prof.
Organizational Affiliation
University of Luebeck - Department of Ophthalmology: Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Luebeck - Department of Ophthalmology
City
Lübeck
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.uksh.de/Augenklinik_Lübeck/index.html
Description
Link Text: University of Lübeck - Department of Ophthalmology - Germany

Learn more about this trial

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

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