Phase 2
Completed N=56
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
Diabetic Macular Edema · Vitrectomy
Source: ClinicalTrials.gov NCT00799227 ↗
Enrolled (actual)
56
Serious AEs
25.5%
Results posted
Aug 2014
Primary outcomePrimary: Change From Baseline in Central Retinal Thickness in the Study Eye — 403.4; -38.9 Microns
Summary
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Central Retinal Thickness in the Study Eye |
403.4; -38.9 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |
54.5; 3.0 | — |
| SECONDARY Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye |
21.4 | — |
| SECONDARY Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye |
33.3; 57.1; 9.5 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older with diabetic macular edema
- History of vitrectomy
- Central retinal thickness ≥ 275 µm
- Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye
Exclusion Criteria
- Known anticipated need for ocular surgery during the study period
- History of glaucoma or current high eye pressure requiring more than 1 medication
- Uncontrolled systemic disease
- Known allergy to the study medication
- Known steroid-responder
- Use of systemic steroids
- Female subjects that are pregnant, nursing or planning a pregnancy
Data sourced from ClinicalTrials.gov (NCT00799227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.