CClinicalTrials.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

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

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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: 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 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
04

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

  • DrugOzurdex

    Intravitreal injection

    Also known as: dexamethasone implant

  • DrugEylea

    Intravitreal injection

    Also known as: aflibercept

05

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

06

Study locations

1 site
  • Texas Retina Associates
    Dallas, Texas 75231, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion