Phase 3
N=494
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT00168389 ↗Enrolled (actual)
494
Serious AEs
28.2%
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 — 22.1; 18.7; 13.3 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
- Jun 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 |
22.1; 18.7; 13.3 | — |
| SECONDARY Average Change From Baseline in BCVA in the Study Eye |
56.2; 55.9; 56.8; 4.1; 4.3; 1.9 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye |
56.2; 55.9; 56.8; 4.1; 5.0; 0.8 | — |
| SECONDARY Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye |
38.7; 34.3; 23.0 | — |
| SECONDARY Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) |
436.7; 457.4; 468.7; -101.1; -103.9; -37.8 | — |
| SECONDARY 10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye |
50; 51; 150 | — |
| SECONDARY Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals |
14.1; 13.9; 6.1; 14.1; 10.2; 7.9 | — |
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 first 12 months of study;
- 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 (NCT00168389). 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.