Status:
COMPLETED
Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification
Lead Sponsor:
Bay Area Retina Associates
Collaborating Sponsors:
Allergan
Conditions:
Diabetic Macular Edema
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to compare the efficacy of antecedent intravitreal anti-vascular endothelial growth factor therapy vs. Ozurdex in reducing post-cataract surgery related macular ...
Detailed Description
In patients with pre-existing diabetic macular edema, anti-vascular endothelial growth factor therapy (Bevacizumab, ranibizumab, or aflibercept) will be compared to Ozurdex therapy administered 1 week...
Eligibility Criteria
Inclusion
- Age \> 18 years of age
- Gender- All
- Race- All
- Diagnosis of Diabetes (Type 1 or 2) with a concomitant diagnosis of diabetic macular edema as demonstrated on spectral domain optical coherence tomography (Heidelberg Spectralis)
- \>250 microns central foveal thickness
- Able and willing to provide informed consent
Exclusion
- Significant renal disease
- A condition that in the opinion of the investigator would preclude participation
- Participation in another investigational trial within 30 days of randomization
- Application of focal macular laser within 120 days of enrollment
- Administration of Iluvien implant within 3 years of enrollment
- Administration of intravitreal triamcinolone within 3 months of enrollment
- Administration of any anti-vascular endothelial growth factor agent within 30 days of enrollment
- Known hypersensitivity to any of the investigational products
- Blood pressure \>180/110
- Women who are pregnant, lactating, or intend to become pregnant within 1 year of randomization
- Vulnerable populations- including but not limited to wards of the state, cognitively impaired individuals, prisoners, institutionalized individuals
- Individual is planning on moving within 6 months of study enrollment
- Macular edema secondary to cause other than diabetic macular edema
- Ocular condition that, in the opinion of the investigators, may affect course of macular edema during course of study (vein occlusion, uveitis, etc.)
- Evidence of ocular infections
- Evidence of uncontrolled glaucoma
- Known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or Ozurdex
Key Trial Info
Start Date :
November 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03832179
Start Date
November 15 2018
End Date
March 30 2024
Last Update
September 12 2025
Active Locations (1)
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1
Bay Area Retina Associates
Walnut Creek, California, United States, 94598