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

NCT ID: NCT02623673

Last Updated: 2016-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-02-29

Brief Summary

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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

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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).

Conditions

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Macular Edema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Intervention Type DRUG

Interventions

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simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Retina Clinic, Sao Paulo, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Gabriel Costa de Andrade

Gabriel Costa de Andrade

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Retina Clinic / UNIFESP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Retina CLINIC

Identifier Type: -

Identifier Source: org_study_id

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