Trial Condition(s):
Macular Edema
Efficacy and safety of VEGF Trap Eye in diabetic macular edema (DME) with central involvement (VIVID EAST)
Trial Purpose
To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement.
Inclusion Criteria
- Adults ≥ 18 years with type 1 or 2 diabetes mellitus - Subjects with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye - Decrease in vision determined to be primarily the result of DME in the study eye - Best-corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 73 to 24 (20/40 to 20/320) in the study eye
Exclusion Criteria
- Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1 - More than 2 previous macular laser treatments in the study eye - Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1 - Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1 - Active proliferative diabetic retinopathy (PDR) in the study eye - Uncontrolled diabetes mellitus, as defined by HbA1c >12% - Only 1 functional eye even if that eye is otherwise eligible for the study
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Peking Union Medical College Hospital Beijing, China, 100730 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Peking University Third Hospital Beijing, China, 100083 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Beijing Tongren Hospital, Capital Medical University Beijing, China, 100730 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Peking University People's Hospital Beijing, China, 100044 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Eye & Ent Hospital of Fudan University Shanghai, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations The Affiliated Eye Hospital of Wenzhou Medical College Wenzhou, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations West China Hospital,Sichuan University Chengdu, China, 610041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Zhongshan Ophthalmic Center, SUN YAT-SEN University Guangzhou, China, 510064 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations The 1st Affiliated Hosp of the 4th Military Med Uni Xi'an, China, 710032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations 2nd Affiliated Hosp., Zhejiang Univ. College of Medicine Hangzhou, China, 310009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations 2nd Xiangya Hosp., Central South Univ. Changsha, China, 410011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Qingdao Eye Hosp. Qingdao, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Tianjin Medical University Eye Center Tianjin, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Shanghai First People's Hospital Beijing, China, 2000080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Hong Kong Eye Hospital Kowloon, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Queen Mary Hospital Hong Kong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations St. Petersburg Medical University n.a. I.P. Pavlov St. Petersburg, Russia, 197022 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov Moscow, Russia, 127486 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Novosibirsk Branch of FBSI IRTC Eye Microsurgery Novosibirsk, Russia, 630071 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Moscow Scien. Res. Institute of Eye Diseases n.a. Helmholtz Moscow, Russia, 105062 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations TianJin eye hospital Tianjin, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations SHENYANG HE EYE HOSPITAL Shenyang, China, 110034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Daping Hospital, third military medical university Chongqing, China, 400042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Renmin Hosp., Wuhan Univ. Wuhan, China, 430040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Beijing Friendship Hospital,Capital Medical University Beijing, China, 100050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double masked, active controlled, phase III study of the efficacy and safety of repeated doses of intravitreal VEGF Trap Eye in subjects with diabetic macular edema
Trial Type:
Interventional
Intervention Type:
Biological/Vaccine
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Change from Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment.Timeframe: Baseline up to week 52
Secondary Outcome
- Percentage of Participants who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared with Baseline at Week 52 - LOCFVisual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.Timeframe: Baseline up to week 52
- Percentage of Participants who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared with Baseline at Week 52 - LOCFVisual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.Timeframe: Baseline up to week 52
- Percentage of Participants with a Greater than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCFETDRS DRSS: None (level 10); Mild to moderate nonproliferative diabetic retinopathy (DR) (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)Timeframe: Baseline up to week 52
- Change from Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCFCRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.Timeframe: Baseline up to week 52
- Change from Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCFThe NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.Timeframe: Baseline up to week 52
- Change from Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCFThe NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.Timeframe: Baseline up to week 52
Additional Information
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