Clinical trial NCT03908307: Evaluation of OZURDEX® in Patients With Macular Edema Secondary to Retinal Vein Occlusion in China
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Edema
Retinal Vein Occlusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in visual acuity from Baseline
timeFrame: At Month 6
measure: Proportion of patients with a BCVA improvement of 15 letters or more compared to Baseline
timeFrame: At Month 6
measure: BCVA average change from Baseline in area under the curve (AUC) analysis
timeFrame: At Month 6
Secondary outcomes:
measure: Mean change from Baseline in BCVA
timeFrame: After first follow-up visit, at each injection, and at Month 12
measure: Mean change from Baseline in Central Retinal Thickness (CRT)
timeFrame: At Months 6 and 12
measure: Mean change from Baseline in the National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25
timeFrame: At Months 6 and 12
measure: Mean number of OZURDEX injections
timeFrame: During the 12-month study
measure: Mean retreatment interval in months
timeFrame: During the 12-month study
measure: Proportion of patients with 2nd injection
timeFrame: During the 12-month study
measure: Proportion of patients with 3rd injection
timeFrame: During the 12-month study
measure: Time to 2nd injection
timeFrame: During the 12-month study
measure: Time to 3rd injection
timeFrame: During the 12-month study
measure: Correlation between the change of BCVA and extent of leak by fluorescein angiography (FA)
timeFrame: At Month 6
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital /ID# 233616
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital, CMU /ID# 233608
city: Changsha Hunan
country: China
facility: The First Xiangya Hospital of Central South University /ID# 233627
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University /ID# 233688
city: Jinan
country: China
facility: Qilu Hospital of Shandong University /ID# 233605
city: Shanghai
country: China
facility: The Eye and ENT Hospital Affiliated of Fudan Univesity /ID# 233666
city: Shanghai
country: China
facility: Shanghai General Hospital /ID# 233579
city: Shantou
country: China
facility: Joint Shantou International Eye Center of Shantou University and The Chinese Uni /ID# 233580
city: Tianjin
country: China
facility: Tianjin Eye Hospital /ID# 233581
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: