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Completed

NCT Number: NCT03832179

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

Bevacizumab

Other names: Avastin

ranibizumab

Drug

Ranibizumab

Other names: Lucentis

aflibercept

Drug

Aflibercept

Other names: Eylea

Ozurdex

Drug

Ozurdex

Other names: Dexamethasone implant

Primary outcomes

  1. Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy

    Time frame: 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 outcomes

  1. Visual acuity outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bay Area Retina Associates

Other

Collaborators

  • Allergan

Registry information

Acronym: STAMP

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Feb 6, 2019
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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