A prospective, non-randomized, mono-center, cohort study to evaluate the effects of 0.5mg intraocular Ranibizumab (Lucentis) injections on retinal function in patients with diabetic macular edema (DME) during twelve months - Ranibizumab short- and long-term effects on retinal function in wAMD

• Conditions: Retinal function in patients with wet age-related macular degeneration; MedDRA version: 14.0Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disorders

• Registration Number: EUCTR2011-002202-70-DE
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein (UK-SH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-21
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diabetic macular edema with center involvement in at least one eye
• Patients with a central retinal thickness (CRT) > 250 µm
• 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
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 tachyarrythmias requiring ongoing treatment
5. History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
6. Clinically significant impaired renal or hepatic function
7. Stroke within 12 month before trial entry.
8. Pregnancy
9. Known serious allergies to the fluorescein dye use in angiography
10. Known contraindications to the components of Lucentis® formulation.Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol
11. Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months. ;Secondary Objective: • to document changes in best corrected visual acuity (BCVA) measured on 4 meters,<br>• to document changes in microperimetry (absolute scotoma size and fixation) <br>• to document changes in optical coherence tomography (OCT) <br>;Primary end point(s): Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months.