Edema de macula diabético refractario.REFRACTORY MACULAR EDEMA IN DIABETIC PATIENTS
Conditions
Interventions
Trade Name: LUCENTIS 10 mg/ml solución inyectable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
Other descriptive name: RANIBIZUMAB
Concentration unit: mg milligram(s)
C
Sponsors
HOSPITAL SAN PEDRO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diabetic type 1 and 2 patients. Diabetic macular edema, diffuse, refractory to laser treatment (decrease in visual acuity during the last six months treatment, with central thickness >250 microns. Less than very severe diabetic retinopathy. Visual acuity >20/320 Snellen (24 letters ETDRS). 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: Tractional macular edema diagnosed in optical coherence tomography. Cataract that can require surgery in the following one year. Uncontrolled hypertension with medical treatment (>150/95 mm Hg) Bad glycemic control (HbA1C > 10%). Severe nephropathy. Previous hearth attack. Previous brain vascular disease. Pregnancy or intention of it during the following one year (pregnancy test required) Active ocular inflammation Previous vitrectomy in the study eye. Previous anti-glaucoma treatment that can increase macular edema. Use of any drug that can be toxic to the macula. Previous use of anti-angiogenic drug or intravitreous steroid in the study eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effect of intravitreal injections of ranibizumab in improvement of visual acuity and decrease central macular thickness in optical coherence tomography after one year of follow-up;Secondary Objective: Evaluate the number of treatments required for maintenance of the benefit obtained.;Primary end point(s): Primary outcome measures are the percentage of eyes in which best-corrected visual acuity improves at least 5 letters ETDRS at one year follow-up and percentage of eyes in which central macular thickness reduces at least 50 microns in optical coherence tomography. | — |
Countries
Spain
Outcome results
None listed