Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
- Registration Number
- NCT00799227
- Lead Sponsor
- Allergan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 700 µg Dexamethasone Implant Dexamethasone 700 µg dexamethasone implant in the study eye at Day 1
- Primary Outcome Measures
Name Time Method Change From Baseline in Central Retinal Thickness in the Study Eye Baseline, Week 26 Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Baseline, Week 26 BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.
Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye Baseline, Week 26 BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye Baseline, Week 26 Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed \< 10%), and Worsened (leakage area increased ≥ 10%).