Phase 2
N=253
Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT00464685 ↗Enrolled (actual)
253
Serious AEs
19.8%
Results posted
Aug 2014
Primary outcome: Primary: Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye — 27.8; 23.6 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexamethasone (Drug); Sham injection (Drug); Laser Photocoagulation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye |
27.8; 23.6 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye |
57.6; 57.8; 2.9; 2.1 | — |
| SECONDARY Change From Baseline in Central Subfield Retinal Thickness in the Study Eye |
438.4; 430.3; -102.8; -125.3 | — |
| SECONDARY Change From Baseline in the Focal Leakage Area in the Study Eye |
0.6; 1.1; -0.2; -0.7 | — |
| SECONDARY Time to Retreatment in the Study Eye |
189; 196 | — |
Summary
This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.
Eligibility Criteria
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
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 (NCT00464685). 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.