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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 : February 8, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Caesar Luo, MD, FACS, Bay Area Retina Associates

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
Diabetic Macular Edema Cataract Drug: Bevacizumab Drug: Ranibizumab Drug: Aflibercept Drug: Ozurdex 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : November 15, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Anti-vascular endothelial growth factor
Intravitreal Bevacizumab, Ranibizumab, or Aflibercept
Drug: Bevacizumab
Bevacizumab
Other Name: Avastin

Drug: Ranibizumab
Ranibizumab
Other Name: Lucentis

Drug: Aflibercept
Aflibercept
Other Name: Eylea

Experimental: Ozurdex
Intravitreal Ozurdex
Drug: Ozurdex
Ozurdex
Other Name: Dexamethasone implant




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832179


Contacts
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Contact: Caesar Luo, MD 9259436800 cluo@bayarearetina.com
Contact: Farhan Ahmed 9259436800 fahmed@bayarearetina.com

Locations
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United States, California
Bay Area Retina Associates Recruiting
Walnut Creek, California, United States, 94598
Contact: Farhan Ahmed    925-943-6800    fahmed@bayarearetina.com   
Contact: Caesar Luo, MD    9259436800    cluo@bayarearetina.com   
Sub-Investigator: Roger Goldberg, MD, MBA         
Sub-Investigator: Tushar Ranchod, MD         
Sub-Investigator: Subhransu Ray, MD, PhD         
Sub-Investigator: Daniel Ting, MD, PhD         
Sub-Investigator: Stewart Daniels, MD         
Sub-Investigator: Craig Leong, MD         
Sponsors and Collaborators
Bay Area Retina Associates
Allergan
Investigators
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Principal Investigator: Caesar Luo, MD Physician

Publications:

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Responsible Party: Caesar Luo, MD, FACS, Physician, Bay Area Retina Associates
ClinicalTrials.gov Identifier: NCT03832179     History of Changes
Other Study ID Numbers: STAMP
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Cataract
Macular Edema
Edema
Signs and Symptoms
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Dexamethasone
Dexamethasone acetate
Bevacizumab
Ranibizumab
Endothelial Growth Factors
Mitogens
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents