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

University of Luebeck1 site in 1 country25 target enrollmentOctober 2011

ConditionsAge-Related Macular Degeneration

InterventionsLucentis (Ranibizumab)

Overview

Phase: N/A
Intervention: Lucentis (Ranibizumab)
Conditions: Age-Related Macular Degeneration
Sponsor: University of Luebeck
Enrollment: 25
Locations: 1
Primary Endpoint: Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

July 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Luebeck

Responsible Party

Principal Investigator

Dr. Matthias Lueke

Principal Investigator

University of Luebeck

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

Arms & Interventions

Lucentis (Ranibizumab)

Intervention: Lucentis (Ranibizumab)

Outcomes

Primary Outcomes

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 Outcomes

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