Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema

Completed

• Conditions: Macular Edema
• Interventions: Drug: simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg.

• Registration Number: NCT02623673
• Lead Sponsor: Retina Clinic, Sao Paulo, Brazil

Brief Summary

Retrospective cases series is a non-randomized, open-label, single-center investigation (Retina Clinic, São Paulo, Brazil) of patients diagnosed with macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and implant of dexamethasone 0.7mg.

Detailed Description

This retrospective cases series is a non-randomized, open-label, single-center investigation (Retina Clinic, São Paulo, Brazil) approved by the Institutional Review Board of Hospital Oftalmológico de Sorocaba/SP, and adhered to the tenets of the Declaration of Helsinki. Were included patients older than 18 years, treated between April 2014 and July 2015, diagnosed with macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous treatment with intravitreal injection of bevacizumab 1.25mg (Avastin; Genentech, South San Francisco, CA) and intravitreal implant of dexamethasone 0.7mg (Ozurdex; Allergan, Inc, Irvine, CA).

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2015-12
• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-08
• Status Verified: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-14
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• central macular thickness > 300 µm on optical coherence tomography (OCT)
• macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions

Exclusion Criteria

• intravitreal anti-VEGF within 6 weeks
• treatment with laser or intravitreal corticosteroids within 3 months of study entry.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bevacizumab plus dexamethasone 0.7mg	simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg.	simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg

Primary Outcome Measures

Name	Time	Method
Improvement in BCVA	6 months

Trial Locations

Locations (1)

Retina Clinic / UNIFESP; 🇧🇷 São Paulo, Brazil