DIFFUSE DIABETIC MACULAR OEDEMA
Conditions
Interventions
Trade Name: TRIGON DEPOT
Product Name: Triamcinolone acetonide
Product Code: DGFPS 44901
Pharmaceutical Form: Injection*
INN or Proposed INN: Triamcinolone acetonide
Concentration unit: mg milligram(s
Sponsors
IOBA. FACULTAD DE MEDICINA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. TYPE 2 DIABETIC PATIENTS WITH DIABETIC MACULAR OEDEMA AND MILD NON PROLIFERATIVE DIABETIC RETINOPATHY. 2. DIFFUSED OEDEMA IN AFG 3. AGED 50- 75 YEARS 4. VISUAL ACUITY >0.05 5. RETINAL THICKNESS >300 MICRONS 6. INFORMED CONSENT OBTAINED 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. Hb A1 >11% 2. High blood pressure (>150/90) 3. SYSTEMIC CORTICOSTEROIDS 4. GLAUCOMA OR OCULAR HYPERTENSION 5. CARDIAC ARREST 6. ISQUEMIC MACULOPATHY 7. MACULAR TRACTION ON OCT 8. OTHER OCULAR CONDITIONS AFFECTING VISUAL ACUITY
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO STUDY THE EFFICACY OF THE INTRAVITREAL INYECTION OF TRIAMCINOLONA AND TRADITIONAL LASER IN THE CONTROL OF DIABETIC MACULAR OEDEMA ;Secondary Objective: TO EVALUATE THE TOLERANCE AND SAFETY OF INTRAVITREAL TRIAMCINOLONE;Primary end point(s): TO IMPROVE VISUAL ACUITY (ETDRS ACUITY CHARTS) IN PATIENTS WITH DIFUSSE MACULAR OEDEMA COMPARED WITH THE RESULTS OF LASER PHOTOCOAGULATION FOLLOWING ETDRS CRITERIA. | — |
Countries
Spain
Outcome results
None listed