Evaluation of OZURDEX® in Patients With Macular Edema Secondary to Retinal Vein Occlusion in China (YANGTZE)
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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.
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)
Actual Study Start Date :
July 25, 2019
Estimated Primary Completion Date :
September 30, 2021
Estimated Study Completion Date :
September 30, 2021
Resource links provided by the National Library of Medicine
Mean change in visual acuity from Baseline [ Time Frame: At Month 6 ]
Determined by best corrected visual acuity (BCVA)
Proportion of patients with a BCVA improvement of 15 letters or more compared to Baseline [ Time Frame: At Month 6 ]
Measured using the ETDRS visual acuity protocol
BCVA average change from Baseline in area under the curve (AUC) analysis [ Time Frame: At Month 6 ]
Secondary Outcome Measures :
Mean change from Baseline in BCVA [ Time Frame: After first follow-up visit, at each injection, and at Month 12 ]
Mean change from Baseline in Central Retinal Thickness (CRT) [ Time Frame: At Months 6 and 12 ]
Mean change from Baseline in the National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25 [ Time Frame: At Months 6 and 12 ]
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.
Mean number of OZURDEX injections [ Time Frame: During the 12-month study ]
Mean retreatment interval in months [ Time Frame: During the 12-month study ]
Proportion of patients with 2nd injection [ Time Frame: During the 12-month study ]
Proportion of patients with 3rd injection [ Time Frame: During the 12-month study ]
Time to 2nd injection [ Time Frame: During the 12-month study ]
Time to 3rd injection [ Time Frame: During the 12-month study ]
Correlation between the change of BCVA and extent of leak by fluorescein angiography (FA) [ Time Frame: At Month 6 ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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:
Periocular steroid injection
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
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Clinical Study Report (CSR)
After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.