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Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT03832179•Bay Area Retina Associates

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+7 more criteria

Locations (1)

Bay Area Retina Associates

Walnut Creek, California, United States

Key Dates

Start Date

November 15, 2018

Primary Completion Date

September 1, 2023

Completion Date

March 30, 2024

Last Updated

September 12, 2025

Enrollment

ACTUAL participants

Conditions

Diabetic Macular EdemaCataract

Interventions

Bevacizumab

DRUG

Ranibizumab

DRUG

Aflibercept

DRUG

Ozurdex

DRUG

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449936

Diabetic Macular EdemaDME+1 more

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RECRUITINGPHASE3

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449923

Diabetic Macular EdemaDME+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

A Study of Avoralstat In Participants With Diabetic Macular Edema

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