Retinal function in patients with wet age-related macular degeneration MedDRA version: 14.0 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Lucentis 10 mg/ ml Injektionslösung
Product Name: Lucentis
Product Code: S01LA04
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ranibizumab
CAS Number: 347396-82-1
Concent
Sponsors
Universitätsklinikum Schleswig-Holstein (UK-SH)
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, • to document changes in microperimetry (absolute scotoma size and fixation) • to document changes in optical coherence tomography (OCT) ;Primary end point(s): Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months. | — |
Countries
Germany
Outcome results
None listed