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Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery

Primary Purpose

Diabetic Macular Edema, Cataract

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bevacizumab Injection
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age greater than 18 years old with type one or type two diabetes mellitus
  • Center-involving diabetic macular edema with central subfield thickness ≥ 320um on Heidelberg Spectralis optical coherence tomography (OCT) testing
  • Best-corrected electron-early treatment diabetic retinopathy study (E-ETDRS Visual Acuity) visual acuity letter score between 78 to 24
  • Any Lens Opacities Classification System (LOCS) III cataract grade greater than or equal to two

Exclusion Criteria:

  • Presence of macular edema attributable to other causes including but not limited to retinal venous occlusive disease and non-infectious uveitis
  • History of glaucoma
  • History of steroid-induced intraocular pressure (IOP) elevation that required IOP-lowering treatment
  • Optic nerve cup to disc ratio greater than 0.6
  • Active proliferative diabetic retinopathy
  • Presence of other retinal diseases including but not limited to age-related macular degeneration, retinal venous occlusive disease and posterior segment uveitis
  • Any prior intraocular surgery
  • Treatment with any anti-VEGF medication within the past 3 months or intravitreal steroid within the past 6 months
  • Panretinal photocoagulation within the prior 6 months or anticipated need for panretinal photocoagulation within the next 6 months
  • IOP greater than or equal to 25
  • Systolic blood pressure > 180 mmHg or diastolic > 110 mmHg
  • Myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack or treatment for acute congestive heart failure within the past 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Bevacizumab

    Dexamethasone implant

    Arm Description

    Intravitreal injection of 1.25mg/0.05cc bevacizumab

    Intravitreal injection of 0.7mg dexamethasone implant

    Outcomes

    Primary Outcome Measures

    Final visual acuity

    Secondary Outcome Measures

    Final optical coherence tomography central macular thickness
    Total number of intravitreal injections over study period

    Full Information

    First Posted
    August 22, 2019
    Last Updated
    February 17, 2021
    Sponsor
    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    Collaborators
    Allergan, Doheny Image Reading Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04067856
    Brief Title
    Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery
    Official Title
    Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Inadequate patient enrollment
    Study Start Date
    January 1, 2020 (Actual)
    Primary Completion Date
    January 31, 2021 (Actual)
    Study Completion Date
    January 31, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    Collaborators
    Allergan, Doheny Image Reading Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this research is to compare the effectiveness of bevacizumab (Avastin) with another a dexamethasone implant (Ozurdex), with respect to anatomic and visual outcomes as well as injection frequency in subjects undergoing cataract surgery with a concurrent diagnosis of diabetic macular edema (DME).
    Detailed Description
    Subjects over the age of 18 with both: 1) visually significant cataracts requiring cataract surgery and 2) diabetic macular edema (DME) will be enrolled in the study. Subjects with high risk proliferative diabetic retinopathy and any other retinal vascular disease or retinal pathology that may limit vision will be excluded. Baseline photography will be done to quantify the amount of DME and to exclude the presence of proliferative diabetic retinopathy or other retinal vascular or general retinal pathology. Subjects will be randomized to receive either an intravitreal injection of Ozurdex or Avastin at the time of cataract surgery. Subjects will be monitored the day after surgery, one to two weeks after cataract surgery and again monthly thereafter for a total of six visits from the time of cataract surgery with standardized visual acuity measurement, ophthalmologic examination and retinal photography performed at each visit. For the first two months after cataract surgery, subjects receiving Ozurdex will receive an injection of Avastin if the degree of swelling worsens by more than 10% on photography or the vision decreases. For the first two months after cataract surgery, subjects receiving Avastin will receive repeat injections of Avastin on a monthly basis. For each monthly visit thereafter, both groups will receive an intravitreal injection of Avastin if clinically significant DME is present or if vision declines.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Macular Edema, Cataract

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bevacizumab
    Arm Type
    Active Comparator
    Arm Description
    Intravitreal injection of 1.25mg/0.05cc bevacizumab
    Arm Title
    Dexamethasone implant
    Arm Type
    Active Comparator
    Arm Description
    Intravitreal injection of 0.7mg dexamethasone implant
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab Injection
    Other Intervention Name(s)
    dexamethasone implant injection
    Intervention Description
    Intravitreal injection
    Primary Outcome Measure Information:
    Title
    Final visual acuity
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    Final optical coherence tomography central macular thickness
    Time Frame
    6 month
    Title
    Total number of intravitreal injections over study period
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age greater than 18 years old with type one or type two diabetes mellitus Center-involving diabetic macular edema with central subfield thickness ≥ 320um on Heidelberg Spectralis optical coherence tomography (OCT) testing Best-corrected electron-early treatment diabetic retinopathy study (E-ETDRS Visual Acuity) visual acuity letter score between 78 to 24 Any Lens Opacities Classification System (LOCS) III cataract grade greater than or equal to two Exclusion Criteria: Presence of macular edema attributable to other causes including but not limited to retinal venous occlusive disease and non-infectious uveitis History of glaucoma History of steroid-induced intraocular pressure (IOP) elevation that required IOP-lowering treatment Optic nerve cup to disc ratio greater than 0.6 Active proliferative diabetic retinopathy Presence of other retinal diseases including but not limited to age-related macular degeneration, retinal venous occlusive disease and posterior segment uveitis Any prior intraocular surgery Treatment with any anti-VEGF medication within the past 3 months or intravitreal steroid within the past 6 months Panretinal photocoagulation within the prior 6 months or anticipated need for panretinal photocoagulation within the next 6 months IOP greater than or equal to 25 Systolic blood pressure > 180 mmHg or diastolic > 110 mmHg Myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack or treatment for acute congestive heart failure within the past 6 months

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery

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