ClinicalTrials.gg
CompletedNCT03984110COEDUpdated Apr 10, 2024

One Year Trial Evaluating Safety of Ozurdex With Eylea

A Phase 4 interventional study of Ozurdex and Eylea in Diabetic Macular Edema, sponsored by Texas Retina Associates. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by Texas Retina Associates · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2022, 4 years ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetic Macular Edema

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03

In context

Macular Edema

756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.

This study's enrollment of 50 is below the median of 56 across 584 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Texas Retina Associates is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Type 1 or 2 diabetic patients
  2. At least 18 years of age, understands the language of the , 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

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 to any components of Eylea or Ozurdex
  3. Patient has suffered from a stroke or (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 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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 · Drug: Eylea

  • Active comparator
    Eylea Monotherapy

    Eyes receiving intravitreal injection of Eylea every month (as needed per protocol)

    Drug: Eylea

Interventions

  • Intravitreal injection

    Also known as: dexamethasone implant

  • DrugEylea

    Intravitreal injection

    Also known as: aflibercept

06

What researchers measure

Primary outcomes

  1. Central Subfield Thickness (CST)

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

    Time frame: 48 weeks

Secondary outcomes

  1. CST

    Change in CST

    Time frame: 12 weeks, 24 weeks, and 36 weeks

  2. Best Corrected Visual Acuity (BCVA)

    Change in Best Corrected Visual Acuity (BCVA)

    Time frame: 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

    Time frame: 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

    Time frame: 48 weeks

  5. Monthly mean changes from baseline in CST

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

    Time frame: 48 weeks

07

Study locations

1 site
  • Texas Retina Associates
    Dallas, Texas 75231, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2019 to primary completion in Oct 2022, 40 months.

Of 51 non-industry phase 4 interventional studies under Macular Edema, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 43. This study's 40 months is above that.

Counting every sponsor, half of 63 studies reached it within 26 months; a quarter within 15 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2019
First posted
Jun 12, 2019
StartActual
Jun 11, 2019
Primary completionActual
Oct 27, 2022
CompletionActual
Oct 27, 2022
Last update
Apr 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03984110
Lead sponsor
Texas Retina Associates
Collaborators
The Emmes Company, LLC
Responsible party
Sponsor
First posted
Jun 12, 2019
Start date
Jun 11, 2019
Primary completion
Oct 27, 2022
Completion
Oct 27, 2022
Last update
Apr 10, 2024

Study contacts

Ashkan M Abbey, MD
principal investigator · Texas Retina Associates

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dexamethasone Intravitreal Implant

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