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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02623673
Enrollment
20
Registered
2015-12-08
Start date
2015-09-30
Completion date
2016-02-29
Last updated
2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema

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).

Interventions

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

Sponsors

Retina Clinic, Sao Paulo, Brazil
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Improvement in BCVA6 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026