One Year Trial Evaluating Safety of Ozurdex With Eylea (COED)

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

One Year Trial Evaluating Safety of Ozurdex With Eylea (COED)

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Ozurdex; Drug: Eylea

Detailed Description

In this study, the investigators aim to compare the effects of combined use of intravitreal injections of Ozurdex every three3 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 Diabetic Macular Edema and best-corrected visual acuity of 20/40 or worse

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Karen Duignan; Phone Number: 2146926941; Email: kduignan@texasretina.com
• Study Contact Backup: Name: Sally M Arceneaux; Phone Number: 2146926941; Email: sarceneaux@texasretina.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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: Yttrium Aluminum Garnet (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 Anterior Chamber Intraocular Lens (ACIOL) 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-Vascular Endothelial Growth Factor (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 Visual Acuity (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: dexamethasone implant; Drug: Eylea; Intravitreal injection; Other Names: aflibercept
Active Comparator: Eylea Monotherapy; Eyes receiving intravitreal injection of Eylea every month (as needed per protocol)	Drug: Eylea; Intravitreal injection; Other Names: aflibercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Subfield Thickness (CST)	Change in Central Subfield Thickness (CST) on Spectral Domain-Optical Coherence Tomography (SD-OCT)	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monthly mean changes from baseline in CST	Monthly mean changes from baseline in CST as measured by SD-OCT	48 weeks
CST	Change in CST	12 weeks, 24 weeks, and 36 weeks
Best Corrected Visual Acuity (BCVA)	Change in Best Corrected Visual Acuity (BCVA)	12 weeks, 24 weeks, 36 weeks, and 48 weeks
Number of additional Intravitreal Therapy (IVT) aflibercept injections required over 48 weeks	Number of additional Intravitreal Therapy (IVT) aflibercept injections required over 48 weeks	48 weeks
Monthly mean changes from baseline in BCVA	Monthly mean changes from baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters read	48 weeks

Collaborators and Investigators

• Sponsor: Texas Retina Associates
• Collaborators: The Emmes Company, LLC
• Investigators: Principal Investigator: Ashkan M Abbey, MD, Texas Retina Associates

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2019
• Primary Completion (Actual): October 27, 2022
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Aflibercept
• Other Study ID Numbers: TRA-COED-19-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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