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Diabetic Macular EdemaPhase 4COEDNCT03984110

One Year Trial Evaluating Safety of Ozurdex With Eylea

A Phase 4 study testing Ozurdex and Eylea in people with Diabetic Macular Edema, run by Texas Retina Associates at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

One Year Trial Evaluating Safety of Ozurdex With Eylea (COED) Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Ozurdex and Eylea
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
11 Jun 2019to 27 Oct 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Type 1 or 2 diabetic patients
  • 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
  • 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
  • Center-involving DME > 300 µm
  • Baseline BCVA between 20/40 - 20/320
  • 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)

Who cannot join

  • 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.
  • Patients with known hypersensitivity to any components of Eylea or Ozurdex
  • Patient has suffered from a stroke or transient ischemic attack (TIA) in the last 6 months
  • Patients using topical anti-inflammatory medication for the duration of the study
  • Patients with Anterior Chamber Intraocular Lens (ACIOL) and rupture of the posterior lens capsule
  • Prior panretinal photocoagulation or macular laser treatments within 90 days of screening
Show all 20Show fewer
  • Previous vitrectomy
  • 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)
  • Patients with retinal diseases other than diabetes that can affect macular edema
  • 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)
  • Eyes with a history of steroid response (i.e., increase of ≥ 5 mmHg IOP following topical steroid treatment)
  • Female patients who are pregnant or breastfeeding
  • Patients who are unable to attend scheduled follow-up visits throughout the 24-week study
  • Any intravitreal anti-Vascular Endothelial Growth Factor (VEGF) treatment to study eye within 3 months prior to Day 1
  • 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)
  • History of any previous treatment in the study eye with an ocular corticosteroid implant (eg Iluvien, Ozurdex, Retisert)
  • 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)
  • 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.
  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Retina Associates

    Dallas, Texas, 75231

Other trials in United States

About this study

Official title: 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)

Read the 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

Being tested
Ozurdex, Eylea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OzurdexDrug

    Also called dexamethasone implant

    Intravitreal injection

  • EyleaDrug

    Also called aflibercept

    Intravitreal injection

Study groups in NCT03984110
Study groupRoleWhat they receive
Combination of Ozurdex and EyleaExperimentalEyes receiving intravitreal injection of Ozurdex every 3 months (as needed per protocol) and intravitreal injection of Eylea every month (as needed per protocol)
Receives: Drug: Ozurdex; Drug: Eylea
Eylea MonotherapyActive comparatorEyes receiving intravitreal injection of Eylea every month (as needed per protocol)
Receives: Drug: Eylea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central Subfield Thickness (CST)

    Change in Central Subfield Thickness (CST) on Spectral Domain-Optical Coherence Tomography (SD-OCT)

    Measured: 48 weeks

Secondary outcomes (5)

  1. CST

    Change in CST

    Measured: 12 weeks, 24 weeks, and 36 weeks

  2. Best Corrected Visual Acuity (BCVA)

    Change in Best Corrected Visual Acuity (BCVA)

    Measured: 12 weeks, 24 weeks, 36 weeks, and 48 weeks

  3. Number of additional Intravitreal Therapy (IVT) aflibercept injections required over 48 weeks

    Number of additional Intravitreal Therapy (IVT) aflibercept injections required over 48 weeks

    Measured: 48 weeks

  4. 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

    Measured: 48 weeks

  5. Monthly mean changes from baseline in CST

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

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2019
  2. Study start11 Jun 2019
  3. Primary completion27 Oct 2022
  4. Study completion27 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03984110
Sponsor's protocol ID
TRA-COED-19-001
Acronym
COED
Status last verified
Apr 2024
First submitted
11 Jun 2019
Last updated
10 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim IP, Orndahl C, Nyaiburi C, Anand R, Callanan D, Chong D, Coors L, Fuller T, McClellan A, Solley W, Wang R, Williams P, Yonekawa Y, Abbey AM. DEXAMETHASONE IMPLANT AND AFLIBERCEPT COMBINATION THERAPY VERSUS AFLIBERCEPT MONOTHERAPY FOR DIABETIC MACULAR EDEMA: A Prospective, Comparative Trial (COED Trial). Retina. 2026 Sep 1;46(9):1520-1531. doi: 10.1097/IAE.0000000000004858.

    PubMed 41954487

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ozurdex and Eylea in people with Diabetic Macular Edema, run by Texas Retina Associates at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Subfield Thickness (CST) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03984110, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.

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