Phase 3
N=554
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT00168337 ↗Enrolled (actual)
554
Serious AEs
32.7%
Results posted
Aug 2014
Primary outcome: Primary: Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye — 22.3; 18.2; 10.8 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); Sham (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye |
22.3; 18.2; 10.8 | — |
| SECONDARY Average Change From Baseline in BCVA in the Study Eye |
55.9; 55.2; 57.0; 2.9; 2.9; 2.0 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye |
55.9; 55.2; 57.0; 1.3; 1.4; -0.0 | — |
| SECONDARY Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye |
34.6; 29.8; 24.9 | — |
| SECONDARY Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) |
486.0; 475.4; 453.7; -117.9; -131.2; -70.4 | — |
Summary
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.
Eligibility Criteria
Key Inclusion Criteria
- 18 years of age or older with diabetic macular edema;
- Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse);
- Visual acuity in other eye no worse than 20/200
Key Exclusion Criteria
- Known anticipated need for ocular surgery within next 12 months;
- History of glaucoma or current high eye pressure requiring more than 1 medication;
- Uncontrolled systemic disease;
- Known steroid-responder;
- Use of systemic steroids;
- Use of Warfarin/Heparin
Data sourced from ClinicalTrials.gov (NCT00168337). 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.