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

Bay Area Retina Associates

Status and phase: Completed; Phase 4

Conditions: Cataract; Diabetic Macular Edema

Treatments: Drug: Aflibercept; Drug: Bevacizumab; Drug: Ozurdex; Drug: Ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03832179

STAMP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Anti-vascular endothelial growth factor

Active Comparator group

Description:

Intravitreal Bevacizumab, Ranibizumab, or Aflibercept

Treatment:

Drug: Ranibizumab

Drug: Bevacizumab

Drug: Aflibercept

Ozurdex

Experimental group

Description:

Intravitreal Ozurdex

Treatment:

Drug: Ozurdex