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

Sponsor
Bay Area Retina Associates (Other)
Overall Status
Recruiting
CT.gov ID
NCT03832179
Collaborator
Allergan (Industry)
32
1
2
47.5
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
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.Two parallel groups, one group receiving anti-vascular endothelial growth factor and the other group receiving Ozurdex.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification
Actual Study Start Date :
Nov 15, 2018
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Anti-vascular endothelial growth factor

Intravitreal Bevacizumab, Ranibizumab, or Aflibercept

Drug: Bevacizumab
Bevacizumab
Other Names:
  • Avastin
  • Drug: Ranibizumab
    Ranibizumab
    Other Names:
  • Lucentis
  • Drug: Aflibercept
    Aflibercept
    Other Names:
  • Eylea
  • Experimental: Ozurdex

    Intravitreal Ozurdex

    Drug: Ozurdex
    Ozurdex
    Other Names:
  • Dexamethasone implant
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bay Area Retina Associates Walnut Creek California United States 94598

    Sponsors and Collaborators

    • Bay Area Retina Associates
    • Allergan

    Investigators

    • Principal Investigator: Caesar Luo, MD, Physician

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Caesar Luo, MD, FACS, Physician, Bay Area Retina Associates
    ClinicalTrials.gov Identifier:
    NCT03832179
    Other Study ID Numbers:
    • STAMP
    First Posted:
    Feb 6, 2019
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 2, 2022