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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

Brief Summary:
The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Ozurdex Drug: Eylea Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema: A Prospective, Comparative Trial (COED Trial)
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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)
Drug: Ozurdex
Intravitreal injection
Other Name: dexamethasone implant

Drug: Eylea
Intravitreal injection
Other Name: aflibercept

Active Comparator: Eylea Monotherapy
Eyes receiving intravitreal injection of Eylea every month (as needed per protocol)
Drug: Eylea
Intravitreal injection
Other Name: aflibercept




Primary Outcome Measures :
  1. Central Subfield Thickness [ Time Frame: 48 weeks ]
    Change in Central Subfield Thickness on OCT


Secondary Outcome Measures :
  1. Central Subfield Thickness [ Time Frame: 12 weeks, 24 weeks, and 36 weeks ]
    Change in Central Subfield Thickness

  2. Best Corrected Visual Acuity [ Time Frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Change in Best Corrected Visual Acuity

  3. Number of additional IVT aflibercept injections required over 48 weeks [ Time Frame: 48 weeks ]
    Number of additional IVT aflibercept injections required over 48 weeks

  4. Monthly mean changes from baseline in BCVA [ Time Frame: 48 weeks ]
    Monthly mean changes from baseline in BCVA as measured by ETDRS letters read

  5. Monthly mean changes from baseline in CST [ Time Frame: 48 weeks ]
    Monthly mean changes from baseline in CST as measured by SD-OCT



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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:

  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

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): NCT03984110


Contacts
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Contact: Karen Duignan 2146926941 kduignan@texasretina.com
Contact: Sally M Arceneaux 2146926941 sarceneaux@texasretina.com

Locations
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United States, Texas
Texas Retina Associates Recruiting
Dallas, Texas, United States, 75231
Contact: Ashkan M Abbey, MD    214-692-6941    aabbey@texasretina.com   
Sponsors and Collaborators
Texas Retina Associates
The Emmes Company, LLC
Investigators
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Principal Investigator: Ashkan M Abbey, MD Texas Retina Associates

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Responsible Party: Texas Retina Associates
ClinicalTrials.gov Identifier: NCT03984110     History of Changes
Other Study ID Numbers: TRA-COED-19-001
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 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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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action