EUCTR2011-002202-70-DE
Active, not recruiting
Not Applicable
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
niversitätsklinikum Schleswig-Holstein (UK-SH)0 sitesJune 21, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinal function in patients with wet age-related macular degeneration
- Sponsor
- niversitätsklinikum Schleswig-Holstein (UK-SH)
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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