Evaluation of OZURDEX® in Patients With Macular Edema Secondary to Retinal Vein Occlusion in China

Study Overview
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Brief Summary
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This study will take place in China to evaluate the safety and efficacy of OZURDEX implant 700 μg in the treatment of macular edema due to retinal vein occlusion (RVO) in patients who have never received treatment for RVO.

Official Title
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A 12-month, Open-label, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® Implant 700 µg (Dexamethasone) on Patients With Macular Edema Secondary to Retinal Vein Occlusion in China (YANGTZE Study)

Conditions
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Macular Edema, Retinal Vein Occlusion

Intervention / Treatment
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* Drug: OZURDEX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: Patient diagnosed with macular edema due to RVO (either BRVO or CRVO, non-ischemic) Retinal thickness ≥ 300 μm by SD-OCT in the central 1 mm macular subfield of the study eye at the Screening visit BCVA score of 19 to 73 letters (approximately 20/400 to 20/40 Snellen equivalent) in the study eye measured by ETDRS method at Screening < 3 months of macular edema duration Treatment-naive patients (ie, have not previously received any treatment for macular edema secondary to RVO) Exclusion Criteria: Uncontrolled systemic disease Presence of/history of any ocular condition other than macular edema that affects visual acuity (eg, cataract, severe macular ischemia, foveal atrophy, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, prior macular detachment) Any of the following ≤ 3 months before study entry or anticipated need within the coming 3 months: Intraocular surgery Laser photocoagulation Intraocular injection Periocular steroid injection Vitrectomized eye Aphakic eyes with ruptured posterior lens capsule or presence of an ACIOL, iris or transscleral fixated intraocular lens History of marked IOP elevation in response to steroid treatment that (a) required IOP-lowering treatment, (b) resulted in a >10 mm Hg increase in IOP from predose, or (c) resulted in IOP >25 mm Hg History of glaucoma or ocular hypertension (IOP > 21 mm Hg), or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in the study eye (patients with a history of previous angle closure that has been successfully treated with either a laser or surgical peripheral iridotomy [PI] are allowed as long as the visual fields have been stable for > 1 year prior to study entry and the patient has been and can be safely dilated). Any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at the Screening 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 that may interfere or preclude participation in the study Use of systemic steroids (e.g., oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to Baseline or anticipated use at any time during the study (inhaled, intranasal, and intra-articular/intrabursal corticosteroids are allowed) Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to Baseline or anticipated use at any time during the study Use of warfarin or heparin within 2 weeks prior to Baseline or anticipated use within the study period Known allergy, hypersensitivity or contraindication to the study medication, its components, fluorescein or povidone iodine Current enrollment in another drug or device study within 30 days prior to Baseline

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Eye<br>OZURDEX implant 700 μg | Drug: OZURDEX<br>* Implant 700 μg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in visual acuity from Baseline | Determined by best corrected visual acuity (BCVA) | At Month 6 | 
| Proportion of patients with a BCVA improvement of 15 letters or more compared to Baseline | Measured using the ETDRS visual acuity protocol | At Month 6 | 
| BCVA average change from Baseline in area under the curve (AUC) analysis |  | At Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in BCVA |  | After first follow-up visit, at each injection, and at Month 12 | 
| Mean change from Baseline in Central Retinal Thickness (CRT) |  | At Months 6 and 12 | 
| Mean change from Baseline in the National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25 | 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Original numeric values from the survey will be recoded with the worst and best possible scores set at 0 and 100 points, respectively. In this format, scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. | At Months 6 and 12 | 
| Mean number of OZURDEX injections |  | During the 12-month study | 
| Mean retreatment interval in months |  | During the 12-month study | 
| Proportion of patients with 2nd injection |  | During the 12-month study | 
| Proportion of patients with 3rd injection |  | During the 12-month study | 
| Time to 2nd injection |  | During the 12-month study | 
| Time to 3rd injection |  | During the 12-month study | 
| Correlation between the change of BCVA and extent of leak by fluorescein angiography (FA) |  | At Month 6 |