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

• Sponsor: Texas Retina Associates (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03984110
• Collaborator: The Emmes Company, LLC (Industry)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.1
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 11, 2019
• Anticipated Primary Completion Date: Jun 15, 2020
• Anticipated Study Completion Date: Jun 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Central Subfield Thickness [48 weeks]

   Change in Central Subfield Thickness on OCT

Secondary Outcome Measures

1. Central Subfield Thickness [12 weeks, 24 weeks, and 36 weeks]

   Change in Central Subfield Thickness

2. Best Corrected Visual Acuity [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 [48 weeks]

   Number of additional IVT aflibercept injections required over 48 weeks

4. Monthly mean changes from baseline in BCVA [48 weeks]

   Monthly mean changes from baseline in BCVA as measured by ETDRS letters read

5. Monthly mean changes from baseline in CST [48 weeks]

   Monthly mean changes from baseline in CST as measured by SD-OCT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Retina Associates	Dallas	Texas	United States	75231

Sponsors and Collaborators

• Texas Retina Associates
• The Emmes Company, LLC

Investigators

• Principal Investigator: Ashkan M Abbey, MD, Texas Retina Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Texas Retina Associates
• ClinicalTrials.gov Identifier: NCT03984110
• Other Study ID Numbers: TRA-COED-19-001
• First Posted: Jun 12, 2019
• Last Update Posted: Jun 12, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Macular Edema; Edema; Dexamethasone; Aflibercept

Study Results

No Results Posted as of Jun 12, 2019