Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF

Study Overview
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Brief Summary
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To determine if Ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have not demonstrated a significant response.

Detailed Description
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To determine whether Ozurdex implant can offer an efficacious alternative for treatment of macular edema in the setting of retinal vein occlusion when treatment with intravitreal bevacizumab (Avastin),ranibizumab (Lucentis), and/or aflibercept (Eylea) have not demonstrated significant response.

Official Title
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Dexamethasone Intravitreal Implant for Retinal Vein Occlusion Associated Macular Edema After Treatment Failure With Anti-VEGF Medications

Conditions
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Retinal Vein Occlusion (RVO), Macular Edema

Intervention / Treatment
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* Drug: Ozurdex implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months. Exclusion Criteria: Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes Interval surgical intervention, such as cataract surgery, that may confound visual outcomes. Pregnancy Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including: Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases) Advanced glaucoma Aphakic eyes with rupture or missing posterior lens capsule Eyes with anterior chamber intraocular lens and missing posterior lens capsule Patients with known hypersensitivity to components of this product

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ozurdex implant<br>Intravitreal injection of Ozurdex implant | Drug: Ozurdex implant<br>* Intravitreal injection of Dexamethasone implant<br>* Other names: Dexamethasone implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography |  | 6 Months |