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The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema: A Prospective, Comparative Trial (COED Trial)

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ClinicalTrials.gov Identifier: NCT03984110
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
The Emmes Company, LLC
Information provided by (Responsible Party):
Texas Retina Associates

Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE June 11, 2019
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
Central Subfield Thickness [ Time Frame: 48 weeks ]
Change in Central Subfield Thickness on OCT
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Central Subfield Thickness [ Time Frame: 12 weeks, 24 weeks, and 36 weeks ]
    Change in Central Subfield Thickness
  • Best Corrected Visual Acuity [ Time Frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Change in Best Corrected Visual Acuity
  • Number of additional IVT aflibercept injections required over 48 weeks [ Time Frame: 48 weeks ]
    Number of additional IVT aflibercept injections required over 48 weeks
  • Monthly mean changes from baseline in BCVA [ Time Frame: 48 weeks ]
    Monthly mean changes from baseline in BCVA as measured by ETDRS letters read
  • Monthly mean changes from baseline in CST [ Time Frame: 48 weeks ]
    Monthly mean changes from baseline in CST as measured by SD-OCT
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema: A Prospective, Comparative Trial (COED Trial)
Official Title  ICMJE The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema: A Prospective, Comparative Trial (COED Trial)
Brief Summary The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema
Detailed Description In this study, we aim to compare the effects of combined use of intravitreal injections of Ozurdex every 3 months and monthly Eylea (aflibercept) to monthly intravitreal injections of aflibercept alone as measured by improvement in central subfield thickness from baseline at Week 48 in eyes with center-involving DME and best-corrected visual acuity (BCVA) of 20/40 or worse
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • Drug: Ozurdex
    Intravitreal injection
    Other Name: dexamethasone implant
  • Drug: Eylea
    Intravitreal injection
    Other Name: aflibercept
Study Arms  ICMJE
  • Experimental: Combination of Ozurdex and Eylea
    Eyes receiving intravitreal injection of Ozurdex every 3 months (as needed per protocol) and intravitreal injection of Eylea every month (as needed per protocol)
    Interventions:
    • Drug: Ozurdex
    • Drug: Eylea
  • Active Comparator: Eylea Monotherapy
    Eyes receiving intravitreal injection of Eylea every month (as needed per protocol)
    Intervention: Drug: Eylea
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2021
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Type 1 or 2 diabetic patients
  2. At least 18 years of age, understands the language of the informed consent, and is willing and able to provide written informed consent before any study procedures
  3. Pseudophakic or phakic lens status with intact posterior lens capsule and/or Nd:YAG laser capsulotomy that in the investigator's opinion is not likely to permit dislocation of Ozurdex implant into the anterior chamber
  4. Center-involving DME > 300 µm
  5. Baseline BCVA between 20/40 - 20/320
  6. Eyes with intraocular pressure (IOP) ≤ 21 and / or treatment with < 2 topical IOP-lowering medications (eyes with history of previous angle -closure or similar conditions that have been successfully treated with either laser or surgical intervention are allowed as long as the visual fields and optic nerves have been stable for > 1 year prior to study entry and the patient has been and can be safely dilated)

Exclusion Criteria:

  1. Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
  2. Patients with known hypersensitivity to any components of Eylea or Ozurdex
  3. Patient has suffered from a stroke or transient ischemic attack (TIA) in the last 6 months
  4. Patients using topical anti-inflammatory medication for the duration of the study
  5. Patients with ACIOL (Anterior Chamber Intraocular Lens) and rupture of the posterior lens capsule
  6. Prior panretinal photocoagulation or macular laser treatments within 90 days of screening
  7. Previous vitrectomy
  8. Any ocular condition that in the opinion of the investigator would not permit improvement of visual acuity with resolution of DME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates and/or poor foveal architecture suggestive of photoreceptor loss)
  9. Patients with retinal diseases other than diabetes that can affect macular edema
  10. Eyes with a history of advanced glaucoma (optic nerve head change consistent with glaucoma damage and/or glaucomatous visual field loss), uncontrolled ocular hypertension (baseline IOP > 21 mmHg despite use of ≥ 2 topical IOP-lowering medication)
  11. Eyes with a history of steroid response (i.e., increase of ≥ 5 mmHg IOP following topical steroid treatment)
  12. Female patients who are pregnant or breastfeeding
  13. Patients who are unable to attend scheduled follow-up visits throughout the 24-week study
  14. Any intravitreal anti-VEGF treatment to study eye within 3 months prior to Day 1
  15. Use of systemic steroid, anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment or anticipated use during the study (these drugs are prohibited from use during the study)
  16. History of any previous treatment in the study eye with an ocular corticosteroid implant (eg Iluvien, Ozurdex, Retisert)
  17. Has scarring from laser photocoagulation in the study eye that would compromise VA; or scarring or abnormality from other macular condition, in the investigator's medical judgement, would limit VA (such as an epiretinal membrane or macular hole)
  18. Has significant media opacity precluding evaluation of retina and vitreous in the study eye. This includes cataract that is felt to be a major contributor to reduced visual acuity and/or likely to undergo surgical repair within 3 months of randomization.
  19. Has any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study (eg, infection, uncontrolled elevated blood pressure, cardiovascular disease, poor glycemic control) or put the subject at risk due to study treatment or procedures
  20. Has had a myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 1 month before enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Karen Duignan 2146926941 kduignan@texasretina.com
Contact: Sally M Arceneaux 2146926941 sarceneaux@texasretina.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984110
Other Study ID Numbers  ICMJE TRA-COED-19-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Texas Retina Associates
Study Sponsor  ICMJE Texas Retina Associates
Collaborators  ICMJE The Emmes Company, LLC
Investigators  ICMJE
Principal Investigator: Ashkan M Abbey, MD Texas Retina Associates
PRS Account Texas Retina Associates
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP