Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification



Status:Recruiting
Conditions:Cardiology, Ocular, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:November 15, 2018
End Date:October 30, 2019
Contact:Caesar Luo, MD
Email:cluo@bayarearetina.com
Phone:9259436800

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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 edema in patients with pre-existing diabetic macular edema.

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 prior to phacoemulsification cataract extraction. Spectral domain optical
coherence tomography and visual acuity will be acquired at 1 week, 1 month, 2 months, and 3
months following cataract surgery.

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
1
site
Walnut Creek, California 94598
Phone: 925-943-6800
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Walnut Creek, CA
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