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NCT02623673 Clinical Trial

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

Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02623673
Other study ID # Retina CLINIC
Secondary ID
Status Completed
Phase N/A
First received December 3, 2015
Last updated February 14, 2016
Start date September 2015
Est. completion date February 2016

Study information
Verified date February 2016
Source Retina Clinic, Sao Paulo, Brazil
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Brazil Retina Clinic / UNIFESP São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Retina Clinic, Sao Paulo, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in BCVA 6 months No
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