EUCTR2011-002202-70-DEActive, not recruitingNot 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 sitesStarted: June 21, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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