Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema

Study Overview
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Brief Summary
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To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.

Detailed Description
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Statistics throughout this study referred to the number of eyes rather than the number of subjects. Subjects were allowed to have both eyes in the study provided that inclusion/exclusion criteria were met. Five subjects had both eyes in the study; 45 subjects were actually enrolled, resulting in 50 study eyes.

Official Title
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A 10 Month, Single Masked, Randomized Controlled Study to Assess Anti-VEGF Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Ozurdex
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male of female age 18 years or older Type 1 or Type 2 diabetes Best corrected visual acuity (BCVA) score of >24 and <78 letters History of at least 3 anti-VEGF intravitreal injections over the past 5 months Presence of macular edema defined as central subfield thickness of >340 microns on Cirrus OCT Exclusion Criteria: Anti-VEGF intravitreal treatment in the last 4 weeks Intravitreal steroid treatment in the last 8 weeks or Ozurdex in the last 4 months Pan retinal photocoagulation (PRP) or focal laser in the last 4 months Active iris neovascularization Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result Uncontrolled systemic disease Known history of intraocular pressure (IOP) elevation in response to corticosteroid treatment, that is not controlled on 2 glaucoma medications Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the baseline visit Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception Any condition or reason (including inability to read early treatment diabetic retinopathy study (ETDRS) chart or language barrier) that precludes the patient's ability to comply with study requirements including completion of the study 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. Aphakia or pseudophakia with anterior chamber intraocular lens Hypersensitivity to any components of Ozurdex or Avastin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bevacizumab<br>1.25 mg intravitreal injection given monthly during a 6 month period | Drug: Bevacizumab<br>* antiVEGF<br>* Other names: Avastin;|
| Active Comparator: Ozurdex<br>Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections | Drug: Ozurdex<br>* intravitreal steroid<br>* Other names: Dexamethasone Intravitreal Implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Visual Acuity Change | Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change. | baseline to month 7 | 
| Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven | Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement. | baseline to month seven |