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

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ClinicalTrials.gov Identifier: NCT03832179
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Caesar Luo, MD, FACS, Bay Area Retina Associates

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE February 6, 2019
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE November 15, 2018
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
Reduction in diabetic macular edema [ Time Frame: 3 months after cataract surgery ]
Compare reduction in diabetic macular edema as measured by spectral domain optical coherence tomography
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
Visual Acuity [ Time Frame: 3 months after cataract surgery ]
Compare change in visual acuity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification
Official Title  ICMJE Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two parallel groups, one group receiving anti-vascular endothelial growth factor and the other group receiving Ozurdex.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Macular Edema
  • Cataract
Intervention  ICMJE
  • Drug: Bevacizumab
    Bevacizumab
    Other Name: Avastin
  • Drug: Ranibizumab
    Ranibizumab
    Other Name: Lucentis
  • Drug: Aflibercept
    Aflibercept
    Other Name: Eylea
  • Drug: Ozurdex
    Ozurdex
    Other Name: Dexamethasone implant
Study Arms  ICMJE
  • Active Comparator: Anti-vascular endothelial growth factor
    Intravitreal Bevacizumab, Ranibizumab, or Aflibercept
    Interventions:
    • Drug: Bevacizumab
    • Drug: Ranibizumab
    • Drug: Aflibercept
  • Experimental: Ozurdex
    Intravitreal Ozurdex
    Intervention: Drug: Ozurdex
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2019)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Caesar Luo, MD 9259436800 cluo@bayarearetina.com
Contact: Farhan Ahmed 9259436800 fahmed@bayarearetina.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03832179
Other Study ID Numbers  ICMJE STAMP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Caesar Luo, MD, FACS, Bay Area Retina Associates
Study Sponsor  ICMJE Bay Area Retina Associates
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Caesar Luo, MD Physician
PRS Account Bay Area Retina Associates
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP