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

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)

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.

Study Overview

• Status: Completed
• Conditions: Macular Edema; Retinal Vein Occlusion
• Intervention / Treatment: Drug: OZURDEX

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Beijing Tongren Hospital, CMU /ID# 233608
  • Changsha Hunan, China, 410008
    • The First Xiangya Hospital of Central South University /ID# 233627
  • Dalian, China, 116011
    • The First Affiliated Hospital of Dalian Medical University /ID# 233688
  • Jinan, China, 250012
    • Qilu Hospital of Shandong University /ID# 233605
  • Shanghai, China, 200031
    • The Eye and ENT Hospital Affiliated of Fudan Univesity /ID# 233666
  • Shanghai, China, 200080
    • Shanghai General Hospital /ID# 233579
  • Shantou, China, 515041
    • Joint Shantou International Eye Center of Shantou University and The Chinese Uni /ID# 233580
  • Tianjin, China, 300020
    • Tianjin Eye Hospital /ID# 233581
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital /ID# 233616

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Eye; OZURDEX implant 700 μg	Drug: OZURDEX; Implant 700 μg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Actual): September 26, 2021
• Study Completion (Actual): September 26, 2021

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: CMO-MA-EYE-0575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No