Phase 2 N=56 Treatment

Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

Diabetic Macular Edema · Vitrectomy

Bottom Line

View on ClinicalTrials.gov: NCT00799227 ↗

Enrolled (actual)

Serious AEs

25.5%

Results posted

Aug 2014

Primary outcome: Primary: Change From Baseline in Central Retinal Thickness in the Study Eye — 403.4; -38.9 Microns

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dexamethasone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Central Retinal Thickness in the Study Eye	403.4; -38.9	—
SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	54.5; 3.0	—
SECONDARY Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye	21.4	—
SECONDARY Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye	33.3; 57.1; 9.5	—

Summary

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

Eligibility Criteria

Inclusion Criteria

18 years of age or older with diabetic macular edema
History of vitrectomy
Central retinal thickness ≥ 275 µm
Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye

Exclusion Criteria

Known anticipated need for ocular surgery during the study period
History of glaucoma or current high eye pressure requiring more than 1 medication
Uncontrolled systemic disease
Known allergy to the study medication
Known steroid-responder
Use of systemic steroids
Female subjects that are pregnant, nursing or planning a pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00799227). 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.