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
One Year Trial Evaluating Safety of Ozurdex With Eylea (COED)
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
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Eyes receiving intravitreal injection of Eylea every month (as needed per protocol)
Drug: Eylea
Central Subfield Thickness (CST)
Change in Central Subfield Thickness (CST) on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Time frame: 48 weeks
CST
Change in CST
Time frame: 12 weeks, 24 weeks, and 36 weeks
Best Corrected Visual Acuity (BCVA)
Change in Best Corrected Visual Acuity (BCVA)
Time frame: 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
Time frame: 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
Time frame: 48 weeks
Monthly mean changes from baseline in CST
Monthly mean changes from baseline in CST as measured by SD-OCT
Time frame: 48 weeks
Plan to share: No
No publications or documents are linked to this record.
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.
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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Studies of the drug tested here: Dexamethasone Intravitreal Implant
Texas Retina Associates