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 |
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.
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.
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
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