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
Exclusion Criteria:
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
Intravitreal injection
Also known as: dexamethasone implant
Intravitreal injection
Also known as: aflibercept
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
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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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Texas Retina Associates