Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908307
Recruitment Status : Active, not recruiting
First Posted : April 9, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment Phase
Macular Edema Retinal Vein Occlusion Drug: OZURDEX Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
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

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Study Eye
OZURDEX implant 700 μg
Drug: OZURDEX
Implant 700 μg




Primary Outcome Measures :
  1. Mean change in visual acuity from Baseline [ Time Frame: At Month 6 ]
    Determined by best corrected visual acuity (BCVA)

  2. 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

  3. BCVA average change from Baseline in area under the curve (AUC) analysis [ Time Frame: At Month 6 ]

Secondary Outcome Measures :
  1. Mean change from Baseline in BCVA [ Time Frame: After first follow-up visit, at each injection, and at Month 12 ]
  2. Mean change from Baseline in Central Retinal Thickness (CRT) [ Time Frame: At Months 6 and 12 ]
  3. 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.

  4. Mean number of OZURDEX injections [ Time Frame: During the 12-month study ]
  5. Mean retreatment interval in months [ Time Frame: During the 12-month study ]
  6. Proportion of patients with 2nd injection [ Time Frame: During the 12-month study ]
  7. Proportion of patients with 3rd injection [ Time Frame: During the 12-month study ]
  8. Time to 2nd injection [ Time Frame: During the 12-month study ]
  9. Time to 3rd injection [ Time Frame: During the 12-month study ]
  10. Correlation between the change of BCVA and extent of leak by fluorescein angiography (FA) [ Time Frame: At Month 6 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908307


Locations
Layout table for location information
China, Guangdong
Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong, China, 515041
China, Hunan
The First Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
China, Liaoning
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116011
China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
China
Beijing Tong Ren Hospital
Beijing, China, 100730
Peking Union medical college hospital
Beijing, China, 100730
Eye & ENT Hospital of Fudan University
Shanghai, China, 200031
Shanghai General Hospital
Shanghai, China, 200080
Tianjin Eye Hospital
Tianjin, China, 300020
Sponsors and Collaborators
Allergan
Investigators
Layout table for investigator information
Study Director: Sushil Panda, MD Allergan
Additional Information:
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03908307    
Other Study ID Numbers: CMO-MA-EYE-0575
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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.
URL: http://www.allerganclinicaltrials.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action