A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

Conditions
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Macular Edema, Retinal Vein Occlusion

Intervention / Treatment
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* Drug: 700 µg Dexamethasone
* Drug: 350 µg Dexamethasone
* Other: Sham Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older with macular edema resulting from retinal vein occlusion Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse) Visual acuity in other eye no worse than 20/200 Exclusion Criteria: Known anticipated need for ocular surgery within next 12 months History of glaucoma or current high eye pressure requiring more than 1 medication Diabetic retinopathy Uncontrolled systemic disease Known steroid-responder Use of systemic steroids Use of warfarin/heparin

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 700 µg Dexamethasone<br>700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. | Drug: 700 µg Dexamethasone<br>* 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.<br>* Other names: Posurdex®;|
| Experimental: 350 µg Dexamethasone followed by 700 µg Dexamethasone<br>350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. | Drug: 700 µg Dexamethasone<br>* 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.<br>* Other names: Posurdex®;Drug: 350 µg Dexamethasone<br>* 350 µg Dexamethasone intravitreal implant administered on Day 0.<br>* Other names: Posurdex®;|
| Sham Comparator: Sham Injection followed by 700 µg Dexamethasone<br>Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. | Drug: 700 µg Dexamethasone<br>* 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.<br>* Other names: Posurdex®;Other: Sham Injection<br>* Sham injection on Day 0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Response Rate of 15 or More Letter Improvement | The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response. | Up to 180 Days | 

Secondary 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 at each visit are presented. | Day 90, Day 180 | 
| Change From Baseline in Retinal Thickness in the Study Eye | Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement. | Baseline, Day 90, Day 180 | 
| Percentage of Patients With a Change From Baseline in BCVA by Category | 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening. | Baseline, Day 90 | 
| Percentage of Patients With a Change From Baseline in BCVA by Category | 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening. | Baseline, Day 180 |