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

Not Applicable

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: Lucentis (Ranibizumab)

• Registration Number: NCT01638858
• Lead Sponsor: University of Luebeck

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-12
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lucentis (Ranibizumab)	Lucentis (Ranibizumab)	-

Primary Outcome Measures

Name	Time	Method
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months	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

Name	Time	Method
to document changes in best corrected visual acuity measured on 4 meters	12 months	to document changes in best corrected visual acuity measured on 4 meters
to document changes in microperimetry	12 months	to document changes in microperimetry
to document changes in optical coherence tomography (OCT)	12 months	to document changes in optical coherence tomography (OCT)

Trial Locations

Locations (1)

University of Luebeck - Department of Ophthalmology; 🇩🇪 Lübeck, Germany