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

Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04067856
Collaborator
Allergan (Industry), Doheny Image Reading Center (Other)
0
Enrollment
2
Arms
13
Actual Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Bevacizumab Injection
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Jan 31, 2021
Actual Study Completion Date :
Jan 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bevacizumab

Intravitreal injection of 1.25mg/0.05cc bevacizumab

Drug: Bevacizumab Injection
Intravitreal injection
Other Names:
  • dexamethasone implant injection

    		•
    Active Comparator: Dexamethasone implant

    Intravitreal injection of 0.7mg dexamethasone implant

    Drug: Bevacizumab Injection
    Intravitreal injection
    Other Names:
  • dexamethasone implant injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Final visual acuity [6 month]

    Secondary Outcome Measures

    1. Final optical coherence tomography central macular thickness [6 month]

    2. Total number of intravitreal injections over study period [6 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Allergan
    • Doheny Image Reading Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pradeep Prasad, Assistant Clinical Professor of Ophthalmology, UCLA, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    ClinicalTrials.gov Identifier:
    NCT04067856
    Other Study ID Numbers:
    • 22361-01
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Cataract
    Macular Edema
    Edema
    Dexamethasone
    Bevacizumab

    Study Results

    No Results Posted as of Feb 21, 2021