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

• Status: Recruiting
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bay Area Retina Associates
• Collaborator: Allergan
• Treatments: Aflibercept; BB 1101; Bevacizumab; Dexamethasone; Dexamethasone acetate; Endothelial Growth Factors; Mitogens; Ranibizumab

Criteria

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