Phase 3
Completed N=956
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
Source: ClinicalTrials.gov NCT00344968 ↗Enrolled (actual)
956
Serious AEs
77.1%
Results posted
May 2014
Primary outcomePrimary: Visual Acuity — 18.9; 28.7; 27.8 percentage of subjects
Summary
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
18.9; 28.7; 27.8 | — |
| SECONDARY Retinal Thickness |
146.1; 113.5; 131.8 | — |
Eligibility Criteria
Inclusion Criteria
- Age >= 18 years with diabetic macular edema
- Diagnosis of diabetes mellitus types 1 or 2
- Best corrected visual acuity of 19-68 letters
- Retinal thickness > 250 micron by OCT
- Investigator is comfortable deferring macular laser treatment for 6 weeks
Exclusion Criteria
- Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with IOP lowering agents
- Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
- Prior intravitreal, subtenon, or periocular steroid therapy within 6 months
- Any ocular surgery within the last 3 months
- Retinal laser treatment within the last 3 months
- History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
- Any lens opacity which impairs visualization of the posterior pole
Data sourced from ClinicalTrials.gov (NCT00344968). 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.