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

Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638858
• Other study ID #: Lucentis_DME_ERG
• Secondary ID: 2011-002202-70
• Status: Completed
• Phase: N/A
• First received: July 2, 2012
• Last updated: July 4, 2014
• Start date: October 2011

Study information

• Verified date: July 2014
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration
• Macular Edema

Intervention

Drug:
• Lucentis (Ranibizumab)
Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

Locations

Country	Name	City	State
Germany	University of Luebeck - Department of Ophthalmology	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months	No
Secondary	to document changes in best corrected visual acuity measured on 4 meters	to document changes in best corrected visual acuity measured on 4 meters	12 months	No
Secondary	to document changes in microperimetry	to document changes in microperimetry	12 months	No
Secondary	to document changes in optical coherence tomography (OCT)	to document changes in optical coherence tomography (OCT)	12 months	No

External Links

•   University of Lübeck - Department of Ophthalmology - Germany