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A 10 Month, Single Masked, Randomized Controlled Study to Assess Anti-VEGF Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema
To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.
Details
| Lead sponsor | Raj K. Maturi, MD |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 45 |
| Start date | 2014-01 |
| Completion | 2015-08 |
Conditions
- Diabetic Macular Edema
Interventions
- Ozurdex
- Bevacizumab
Primary outcomes
- Mean Visual Acuity Change — baseline to month 7
Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change. - Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven — baseline to month seven
Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.
Countries
United States