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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: Lucentis (Ranibizumab)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lucentis (Ranibizumab)<br> | Drug: Lucentis (Ranibizumab)<br>* Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| to document changes in microperimetry | to document changes in microperimetry | 12 months | 
| to document changes in optical coherence tomography (OCT) | to document changes in optical coherence tomography (OCT) | 12 months |