NCT01571232

Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Retina Macula Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.

Detailed description

This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.

Conditions

• Diabetic Macular Edema
• Non-proliferative Diabetic Retinopathy
• Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	dexamethasone intravitreal implant	Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
DRUG	intravitreal bevacizumab	Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-02-01
• Completion: 2015-03-01
• First posted: 2012-04-05
• Last updated: 2021-03-30
• Results posted: 2017-05-31

Locations

1 site across 1 country: United States