Phase 3
Completed N=37
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
Source: ClinicalTrials.gov NCT00490815 ↗Enrolled (actual)
37
Serious AEs
83.8%
Results posted
Feb 2014
Primary outcomePrimary: Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor — 1.4905; 0.7140 pg/ml
Summary
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor |
1.4905; 0.7140 | — |
| SECONDARY Retinal Thickness |
343.8; 324.2 | — |
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 letters
- Retinal thickness > 250 microns 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 the last 3 months
- Prior intravitreal or subtenon anti-VEGF therapy within the last 2 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 (NCT00490815). 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.