| Trial ID: | L2697 |
| Source ID: | NCT00309192
|
| Associated Drug: |
Triamcinolone Acetonide
|
| Title: |
Efficacy and Safety Study of Intravitreal Triamcinolone to Treat Diffuse Diabetic Macular Edema
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Macular Edema
|
| Interventions: |
DRUG: Triamcinolone Acetonide|PROCEDURE: Grid laser|PROCEDURE: Sham Injection
|
| Outcome Measures: |
Primary: Visual acuity stabilization or improvement 6 months after treatment., 6 months|Macular edema reduction or stabilization 6 months after treatment., 6 months | Secondary: Safety of the treatment., 6 months|Tolerance of the treatment., 6 months
|
| Sponsor/Collaborators: |
Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA | Collaborators: Fondo de Investigacion Sanitaria
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
292
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-04
|
| Completion Date: |
2009-07
|
| Results First Posted: |
|
| Last Update Posted: |
2023-03-14
|
| Locations: |
INGO - Instituto Galego de Oftalmoloxia, Santiago de Compostela, La Coruña, Spain|Clínica Universitaria de Navarra, Pamplona, Navarra, Spain|Instituto Oftalmológico de Alicante, Alicante, Spain|Hospital de la Vall D´Hebrón, Barcelona, Spain|Hospital Clínico Universitario San Carlos, Madrid, Spain|Hospital General Universitario Reina Sofía, Murcia, Spain|IOBA - Instituto Universitario de Oftalmobiología Aplicada, Valladolid, 47011, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT00309192
|
