Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)

Study Overview
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Brief Summary
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This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.

Conditions
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Macular Edema

Intervention / Treatment
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* Drug: 700 μg Dexamethasone
* Other: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Exclusion Criteria: History of glaucoma, ocular hypertension or optic nerve head change Any active bacterial, viral, parasitic, or fungal infections in either eye Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start Use of topical ophthalmic corticosticosteroids within 2 weeks of study start

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 700 μg Dexamethasone<br>700 μg Dexamethasone intravitreal injection in the study eye on Day 1. | Drug: 700 μg Dexamethasone<br>* 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.<br>* Other names: Ozurdex®;|
| Sham Comparator: Sham<br>Sham administered in the study eye on Day 1. | Drug: 700 μg Dexamethasone<br>* 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.<br>* Other names: Ozurdex®;Other: Sham<br>* Sham administered in the study eye on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented. | Baseline, 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change From Baseline in BCVA in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening. | Baseline, 6 Months | 
| Change From Baseline in BCVA in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened. | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 | 
| Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening. | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 |