<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03832179</url>
  </required_header>
  <id_info>
    <org_study_id>STAMP</org_study_id>
    <nct_id>NCT03832179</nct_id>
  </id_info>
  <brief_title>Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification</brief_title>
  <acronym>STAMP</acronym>
  <official_title>Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bay Area Retina Associates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bay Area Retina Associates</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to compare the efficacy of antecedent intravitreal&#xD;
      anti-vascular endothelial growth factor therapy vs. Ozurdex in reducing post-cataract surgery&#xD;
      related macular edema in patients with pre-existing diabetic macular edema.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients with pre-existing diabetic macular edema, anti-vascular endothelial growth factor&#xD;
      therapy (Bevacizumab, ranibizumab, or aflibercept) will be compared to Ozurdex therapy&#xD;
      administered 1 week prior to phacoemulsification cataract extraction. Spectral domain optical&#xD;
      coherence tomography and visual acuity will be acquired at 1 week, 1 month, 2 months, and 3&#xD;
      months following cataract surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">October 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two parallel groups, one group receiving anti-vascular endothelial growth factor and the other group receiving Ozurdex.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy</measure>
    <time_frame>3 months after cataract surgery</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual acuity outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy</measure>
    <time_frame>3 months after cataract surgery</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Anti-vascular endothelial growth factor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravitreal Bevacizumab, Ranibizumab, or Aflibercept</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ozurdex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravitreal Ozurdex</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Bevacizumab</description>
    <arm_group_label>Anti-vascular endothelial growth factor</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranibizumab</intervention_name>
    <description>Ranibizumab</description>
    <arm_group_label>Anti-vascular endothelial growth factor</arm_group_label>
    <other_name>Lucentis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aflibercept</intervention_name>
    <description>Aflibercept</description>
    <arm_group_label>Anti-vascular endothelial growth factor</arm_group_label>
    <other_name>Eylea</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ozurdex</intervention_name>
    <description>Ozurdex</description>
    <arm_group_label>Ozurdex</arm_group_label>
    <other_name>Dexamethasone implant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years of age&#xD;
&#xD;
          -  Gender- All&#xD;
&#xD;
          -  Race- All&#xD;
&#xD;
          -  Diagnosis of Diabetes (Type 1 or 2) with a concomitant diagnosis of diabetic macular&#xD;
             edema as demonstrated on spectral domain optical coherence tomography (Heidelberg&#xD;
             Spectralis)&#xD;
&#xD;
          -  &gt;250 microns central foveal thickness&#xD;
&#xD;
          -  Able and willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant renal disease&#xD;
&#xD;
          -  A condition that in the opinion of the investigator would preclude participation&#xD;
&#xD;
          -  Participation in another investigational trial within 30 days of randomization&#xD;
&#xD;
          -  Application of focal macular laser within 120 days of enrollment&#xD;
&#xD;
          -  Administration of Iluvien implant within 3 years of enrollment&#xD;
&#xD;
          -  Administration of intravitreal triamcinolone within 3 months of enrollment&#xD;
&#xD;
          -  Administration of any anti-vascular endothelial growth factor agent within 30 days of&#xD;
             enrollment&#xD;
&#xD;
          -  Known hypersensitivity to any of the investigational products&#xD;
&#xD;
          -  Blood pressure &gt;180/110&#xD;
&#xD;
          -  Women who are pregnant, lactating, or intend to become pregnant within 1 year of&#xD;
             randomization&#xD;
&#xD;
          -  Vulnerable populations- including but not limited to wards of the state, cognitively&#xD;
             impaired individuals, prisoners, institutionalized individuals&#xD;
&#xD;
          -  Individual is planning on moving within 6 months of study enrollment&#xD;
&#xD;
          -  Macular edema secondary to cause other than diabetic macular edema&#xD;
&#xD;
          -  Ocular condition that, in the opinion of the investigators, may affect course of&#xD;
             macular edema during course of study (vein occlusion, uveitis, etc.)&#xD;
&#xD;
          -  Evidence of ocular infections&#xD;
&#xD;
          -  Evidence of uncontrolled glaucoma&#xD;
&#xD;
          -  Known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or&#xD;
             Ozurdex&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caesar Luo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physician</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Caesar Luo, MD</last_name>
    <phone>9259436800</phone>
    <email>cluo@bayarearetina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Farhan Ahmed</last_name>
    <phone>9259436800</phone>
    <email>fahmed@bayarearetina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bay Area Retina Associates</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Farhan Ahmed</last_name>
      <phone>925-943-6800</phone>
      <email>fahmed@bayarearetina.com</email>
    </contact>
    <contact_backup>
      <last_name>Caesar Luo, MD</last_name>
      <phone>9259436800</phone>
      <email>cluo@bayarearetina.com</email>
    </contact_backup>
    <investigator>
      <last_name>Roger Goldberg, MD, MBA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tushar Ranchod, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Subhransu Ray, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel Ting, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stewart Daniels, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Craig Leong, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rauen PI, Ribeiro JA, Almeida FP, Scott IU, Messias A, Jorge R. Intravitreal injection of ranibizumab during cataract surgery in patients with diabetic macular edema. Retina. 2012 Oct;32(9):1799-803. doi: 10.1097/IAE.0b013e31824bebb8.</citation>
    <PMID>22495327</PMID>
  </reference>
  <reference>
    <citation>Furino C, Boscia F, Niro A, Giancipoli E, Grassi MO, D'amico Ricci G, Blasetti F, Reibaldi M, Alessio G. Combined Phacoemulsification and Intravitreal Dexamethasone Implant (Ozurdex(R)) in Diabetic Patients with Coexisting Cataract and Diabetic Macular Edema. J Ophthalmol. 2017;2017:4896036. doi: 10.1155/2017/4896036. Epub 2017 Aug 13.</citation>
    <PMID>28884024</PMID>
  </reference>
  <reference>
    <citation>Calvo P, Ferreras A, Al Adel F, Dangboon W, Brent MH. EFFECT OF AN INTRAVITREAL DEXAMETHASONE IMPLANT ON DIABETIC MACULAR EDEMA AFTER CATARACT SURGERY. Retina. 2018 Mar;38(3):490-496. doi: 10.1097/IAE.0000000000001552.</citation>
    <PMID>28196056</PMID>
  </reference>
  <reference>
    <citation>Yumusak E, Ornek K. Comparison of Perioperative Ranibizumab Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery. J Ophthalmol. 2016;2016:7945619. doi: 10.1155/2016/7945619. Epub 2016 Jul 14.</citation>
    <PMID>27493795</PMID>
  </reference>
  <reference>
    <citation>Lim LL, Morrison JL, Constantinou M, Rogers S, Sandhu SS, Wickremasinghe SS, Kawasaki R, Al-Qureshi S. Diabetic Macular Edema at the time of Cataract Surgery trial: a prospective, randomized clinical trial of intravitreous bevacizumab versus triamcinolone in patients with diabetic macular oedema at the time of cataract surgery - preliminary 6 month results. Clin Exp Ophthalmol. 2016 May;44(4):233-42. doi: 10.1111/ceo.12720. Epub 2016 Mar 29.</citation>
    <PMID>26871700</PMID>
  </reference>
  <reference>
    <citation>Schmier JK, Halpern MT, Covert DW, Matthews GP. Evaluation of costs for cystoid macular edema among patients after cataract surgery. Retina. 2007 Jun;27(5):621-8. doi: 10.1097/01.iae.0000249577.92800.c0.</citation>
    <PMID>17558326</PMID>
  </reference>
  <reference>
    <citation>Hayashi K, Igarashi C, Hirata A, Hayashi H. Changes in diabetic macular oedema after phacoemulsification surgery. Eye (Lond). 2009 Feb;23(2):389-96. doi: 10.1038/sj.eye.6703022. Epub 2007 Oct 26.</citation>
    <PMID>17962820</PMID>
  </reference>
  <reference>
    <citation>Hartnett ME, Tinkham N, Paynter L, Geisen P, Rosenberg P, Koch G, Cohen KL. Aqueous vascular endothelial growth factor as a predictor of macular thickening following cataract surgery in patients with diabetes mellitus. Am J Ophthalmol. 2009 Dec;148(6):895-901.e1. doi: 10.1016/j.ajo.2009.07.014. Epub 2009 Oct 17.</citation>
    <PMID>19837384</PMID>
  </reference>
  <reference>
    <citation>Ferguson VM, Spalton DJ. Continued breakdown of the blood aqueous barrier following cataract surgery. Br J Ophthalmol. 1992 Aug;76(8):453-6. doi: 10.1136/bjo.76.8.453.</citation>
    <PMID>1390524</PMID>
  </reference>
  <reference>
    <citation>Dong N, Xu B, Wang B, Chu L, Tang X. Aqueous cytokines as predictors of macular edema in patients with diabetes following uncomplicated phacoemulsification cataract surgery. Biomed Res Int. 2015;2015:126984. doi: 10.1155/2015/126984. Epub 2015 Feb 25.</citation>
    <PMID>25811020</PMID>
  </reference>
  <reference>
    <citation>Patel JI, Hykin PG, Cree IA. Diabetic cataract removal: postoperative progression of maculopathy--growth factor and clinical analysis. Br J Ophthalmol. 2006 Jun;90(6):697-701. doi: 10.1136/bjo.2005.087403. Epub 2006 Mar 15.</citation>
    <PMID>16540489</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bay Area Retina Associates</investigator_affiliation>
    <investigator_full_name>Caesar Luo, MD, FACS</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Ranibizumab</mesh_term>
    <mesh_term>Aflibercept</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03832179
org study id: STAMP
nct id: NCT03832179
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
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.
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.
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy
time frame: 3 months after cataract surgery
description: 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
measure: Visual acuity outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy
time frame: 3 months after cataract surgery
description: 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
arm group label: Anti-vascular endothelial growth factor
arm group type: Active Comparator
description: Intravitreal Bevacizumab, Ranibizumab, or Aflibercept
arm group label: Ozurdex
arm group type: Experimental
description: Intravitreal Ozurdex
intervention type: Drug
intervention name: Bevacizumab
description: Bevacizumab
arm group label: Anti-vascular endothelial growth factor
other name: Avastin
intervention type: Drug
intervention name: Ranibizumab
description: Ranibizumab
arm group label: Anti-vascular endothelial growth factor
other name: Lucentis
intervention type: Drug
intervention name: Aflibercept
description: Aflibercept
arm group label: Anti-vascular endothelial growth factor
other name: Eylea
intervention type: Drug
intervention name: Ozurdex
description: Ozurdex
arm group label: Ozurdex
other name: Dexamethasone implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Caesar Luo, MD
role: Principal Investigator
affiliation: Physician
last name: Caesar Luo, MD
phone: 9259436800
email: cluo@bayarearetina.com
last name: Farhan Ahmed
phone: 9259436800
email: fahmed@bayarearetina.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
citation: Rauen PI, Ribeiro JA, Almeida FP, Scott IU, Messias A, Jorge R. Intravitreal injection of ranibizumab during cataract surgery in patients with diabetic macular edema. Retina. 2012 Oct;32(9):1799-803. doi: 10.1097/IAE.0b013e31824bebb8.
PMID: 22495327
citation: Furino C, Boscia F, Niro A, Giancipoli E, Grassi MO, D'amico Ricci G, Blasetti F, Reibaldi M, Alessio G. Combined Phacoemulsification and Intravitreal Dexamethasone Implant (Ozurdex(R)) in Diabetic Patients with Coexisting Cataract and Diabetic Macular Edema. J Ophthalmol. 2017;2017:4896036. doi: 10.1155/2017/4896036. Epub 2017 Aug 13.
PMID: 28884024
citation: Calvo P, Ferreras A, Al Adel F, Dangboon W, Brent MH. EFFECT OF AN INTRAVITREAL DEXAMETHASONE IMPLANT ON DIABETIC MACULAR EDEMA AFTER CATARACT SURGERY. Retina. 2018 Mar;38(3):490-496. doi: 10.1097/IAE.0000000000001552.
PMID: 28196056
citation: Yumusak E, Ornek K. Comparison of Perioperative Ranibizumab Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery. J Ophthalmol. 2016;2016:7945619. doi: 10.1155/2016/7945619. Epub 2016 Jul 14.
PMID: 27493795
citation: Lim LL, Morrison JL, Constantinou M, Rogers S, Sandhu SS, Wickremasinghe SS, Kawasaki R, Al-Qureshi S. Diabetic Macular Edema at the time of Cataract Surgery trial: a prospective, randomized clinical trial of intravitreous bevacizumab versus triamcinolone in patients with diabetic macular oedema at the time of cataract surgery - preliminary 6 month results. Clin Exp Ophthalmol. 2016 May;44(4):233-42. doi: 10.1111/ceo.12720. Epub 2016 Mar 29.
PMID: 26871700
citation: Schmier JK, Halpern MT, Covert DW, Matthews GP. Evaluation of costs for cystoid macular edema among patients after cataract surgery. Retina. 2007 Jun;27(5):621-8. doi: 10.1097/01.iae.0000249577.92800.c0.
PMID: 17558326
citation: Hayashi K, Igarashi C, Hirata A, Hayashi H. Changes in diabetic macular oedema after phacoemulsification surgery. Eye (Lond). 2009 Feb;23(2):389-96. doi: 10.1038/sj.eye.6703022. Epub 2007 Oct 26.
PMID: 17962820
citation: Hartnett ME, Tinkham N, Paynter L, Geisen P, Rosenberg P, Koch G, Cohen KL. Aqueous vascular endothelial growth factor as a predictor of macular thickening following cataract surgery in patients with diabetes mellitus. Am J Ophthalmol. 2009 Dec;148(6):895-901.e1. doi: 10.1016/j.ajo.2009.07.014. Epub 2009 Oct 17.
PMID: 19837384
citation: Ferguson VM, Spalton DJ. Continued breakdown of the blood aqueous barrier following cataract surgery. Br J Ophthalmol. 1992 Aug;76(8):453-6. doi: 10.1136/bjo.76.8.453.
PMID: 1390524
citation: Dong N, Xu B, Wang B, Chu L, Tang X. Aqueous cytokines as predictors of macular edema in patients with diabetes following uncomplicated phacoemulsification cataract surgery. Biomed Res Int. 2015;2015:126984. doi: 10.1155/2015/126984. Epub 2015 Feb 25.
PMID: 25811020
citation: Patel JI, Hykin PG, Cree IA. Diabetic cataract removal: postoperative progression of maculopathy--growth factor and clinical analysis. Br J Ophthalmol. 2006 Jun;90(6):697-701. doi: 10.1136/bjo.2005.087403. Epub 2006 Mar 15.
PMID: 16540489
responsible party type: Principal Investigator
investigator affiliation: Bay Area Retina Associates
investigator full name: Caesar Luo, MD, FACS
investigator title: Physician
mesh term: Cataract
mesh term: Macular Edema
mesh term: Edema
mesh term: Dexamethasone
mesh term: Bevacizumab
mesh term: Ranibizumab
mesh term: Aflibercept
sharing ipd: No