Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemul… (NCT03832179) | Clinical Trial Compass
CompletedPhase 4
Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification
United States16 participantsStarted 2018-11-15
Plain-language 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 edema in patients with pre-existing diabetic macular edema.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.)
* Evide…
What they're measuring
1
Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy