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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Implant 700 μg
Peking Union Medical College Hospital /ID# 233616
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, CMU /ID# 233608
Beijing, China
The First Xiangya Hospital of Central South University /ID# 233627
Changsha Hunan, China
Mean change in visual acuity from Baseline
Determined by best corrected visual acuity (BCVA)
Time frame: 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
Time frame: At Month 6
BCVA average change from Baseline in area under the curve (AUC) analysis
Time frame: At Month 6
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
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.
Time frame: At Months 6 and 12
Mean number of OZURDEX injections
Time frame: During the 12-month study
Mean retreatment interval in months
Time frame: During the 12-month study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The First Affiliated Hospital of Dalian Medical University /ID# 233688
Dalian, China
Qilu Hospital of Shandong University /ID# 233605
Jinan, China
The Eye and ENT Hospital Affiliated of Fudan Univesity /ID# 233666
Shanghai, China
Shanghai General Hospital /ID# 233579
Shanghai, China
Joint Shantou International Eye Center of Shantou University and The Chinese Uni /ID# 233580
Shantou, China
Tianjin Eye Hospital /ID# 233581
Tianjin, China
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