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

Phase 4

• Conditions: Diabetic Macular Edema; Cataract
• Interventions: Drug: Ozurdex; Drug: Bevacizumab; Drug: Ranibizumab; Drug: Aflibercept

• Registration Number: NCT03832179
• Lead Sponsor: Bay Area Retina Associates

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 edema in patients with pre-existing diabetic macular edema.

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 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.

Study Timeline

• Study Start: 2018-11-15
• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-07-01
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozurdex	Ozurdex	Intravitreal Ozurdex
Anti-vascular endothelial growth factor	Bevacizumab	Intravitreal Bevacizumab, Ranibizumab, or Aflibercept
Anti-vascular endothelial growth factor	Aflibercept	Intravitreal Bevacizumab, Ranibizumab, or Aflibercept
Anti-vascular endothelial growth factor	Ranibizumab	Intravitreal Bevacizumab, Ranibizumab, or Aflibercept

Primary Outcome Measures

Name	Time	Method
Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy	3 months after cataract surgery	Central foveal thickness will be measured in microns by spectral domain optical coherence tomography (Heidelberg) and compared to baseline at post-operative week 1, postoperative month 1, postoperative month 2, and postoperative month 3 for both anti-vascular endothelial growth factor and Ozurdex groups

Secondary Outcome Measures

Name	Time	Method
Visual acuity outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy	3 months after cataract surgery	Snellen visual acuity will be measured and converted into logMAR and compared to baseline at post-operative week 1, postoperative month 1, postoperative month 2, and postoperative month 3 for both anti-vascular endothelial growth factor and Ozurdex groups

Trial Locations

Locations (1)

Bay Area Retina Associates; 🇺🇸 Walnut Creek, California, United States