Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome
- Sponsor
- European School of Advanced Studies in Ophthalmology
- Study ID
- NCT05080803
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone — DRUGintravitreal administration
Study Details
Retrospective multi-center observational study on functional and morphological outcome of initial therapy for DME according to ESASO Morphologic Classification.
Key Dates
- Start date
- Jun 1, 2021
- Status verified
- Sep 2023
- Primary completion
- Dec 23, 2021
- Completion
- Jul 26, 2022
Study Design
- Enrollment
- 608 participants (actual)
Arms
- Arm: Early DMEFunctional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately
- Arm: Advanced DMEFunctional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately
- Arm: Severe DMEFunctional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately
- Arm: Atrophic diabetic maculopathyFunctional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately
Primary Outcome Measure
Functional and morphological improvement in DME after initial therapeutic loading phase, according to ESASO stage of progression of the disease. [ Time Frame: Four months ]
Related Studies
- Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)PHASE1 · Recruiting · Ocugen · Deerfield Beach, Florida
- EC-104 Intravitreal Implant for the Treatment of Diabetic Macular EdemaPHASE1/PHASE2 · Recruiting · Eclipse Life Sciences, Inc. · Tampa, Florida
- Intranasal Delivery of Octreotide for Treatment of Diabetic Macular EdemaPHASE1 · Not Yet Recruiting · University of Alabama at Birmingham · Birmingham, Alabama
- Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)PHASE2 · Recruiting · Sierra Eye Associates · Reno, Nevada