Diabetic makula edema with visual impairment MedDRA version: 14.0 Level: HLGT Classification code 10012653 Term: Diabetic complications System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: LUCENTIS (ranibizumab)
Product Name: LUCENTIS
Pharmaceutical Form: Solution for injection
Sponsors
Inst of Ophtalmology Lund University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with type 1 or 2 diabetes mellitus patients with clinical significant macular edema patients with visual impairment =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Patients with active proliferative retinopathy 2. Duration of macular edema> two years 3. Cataract which causes impaired VA 4. HbA1c > 10 at baseline 5. B-glucos > 20 at baseline 6. Pregnant or nursing women 7. Fertile women not using effective contraception 8. Patients with active och suspected infection in our around the eye 9. Patientes with severe intraocular inflammation 10. Patients with uncontrolled intraocular pressure (IOP) <25 mmHg in spite of treatment 11. Intraocular surgery during the last 3 months befor enrollment 12. Previous treatment for retinaldisease such as trombosis or diabeticretinophaty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At baseline one and 3 months after injection with ranibizumab;Main Objective: To study if intravitreal injection of Lucentis gives an improved visual function and a reduction of macularedema. And also objectively evaluate changes in the total retinal function and makular function with mfERG och ff ERG. ;Secondary Objective: To study if Lucentis (ranibizumab) given as an injection into the eye can improv vision and reduce the svelling of the macula. And also to evaluate changes in the retinalcell function and makular cellfunction by using an non-invasive method to measure the electical activity of the retina. ;Primary end point(s): Effect on retinalcell and macular cellfunction of treatment with ranibizumab | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): to study if the changes in retinalfunction correlate to visual improvment and morphology changes on Optical Coherance Tomography (OCT);Timepoint(s) of evaluation of this end point: OCT will be done at baseline, 1 and 3 months after injection with ranibizumab. Visual acuity will be measured at every visit, 0, 1,2,3 months | — |
Countries
Sweden
Contacts
Public ContactDoc Monica Lövestam Adrian
Inst of Ophtalmology Lund University Hospital
Outcome results
None listed