Evaluacion de la eficacia y seguridad de la inyección intravítrea de triamcinolona en el tratamiento del edema difuso del diabético - Triamcinolona intravitrea
- Conditions
- DIFFUSE DIABETIC MACULAR OEDEMA
- Registration Number
- EUCTR2005-001385-14-ES
- Lead Sponsor
- IOBA. FACULTAD DE MEDICINA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: TO STUDY THE EFFICACY OF THE INTRAVITREAL INYECTION OF TRIAMCINOLONA AND TRADITIONAL LASER IN THE CONTROL OF DIABETIC MACULAR OEDEMA<br>;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.
- Secondary Outcome Measures
Name Time Method