Trial Condition(s):
Macular Edema
Efficacy and safety of VEGF Trap Eye in diabetic macular edema (DME) with central involvement (VIVID EAST)
Bayer Identifier:
15161
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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 | |
|---|---|
Locations Peking Union Medical College Hospital Beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking University Third Hospital Beijing, China, 100083 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Beijing Tongren Hospital, Capital Medical University Beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking University People's Hospital Beijing, China, 100044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eye & Ent Hospital of Fudan University Shanghai, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Affiliated Eye Hospital of Wenzhou Medical College Wenzhou, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West China Hospital,Sichuan University Chengdu, China, 610041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zhongshan Ophthalmic Center, SUN YAT-SEN University Guangzhou, China, 510064 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The 1st Affiliated Hosp of the 4th Military Med Uni Xi'an, China, 710032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 2nd Affiliated Hosp., Zhejiang Univ. College of Medicine Hangzhou, China, 310009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 2nd Xiangya Hosp., Central South Univ. Changsha, China, 410011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Qingdao Eye Hosp. Qingdao, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tianjin Medical University Eye Center Tianjin, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shanghai First People's Hospital Beijing, China, 2000080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hong Kong Eye Hospital Kowloon, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Mary Hospital Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Petersburg Medical University n.a. I.P. Pavlov St. Petersburg, Russia, 197022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov Moscow, Russia, 127486 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Novosibirsk Branch of FBSI IRTC Eye Microsurgery Novosibirsk, Russia, 630071 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Moscow Scien. Res. Institute of Eye Diseases n.a. Helmholtz Moscow, Russia, 105062 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations TianJin eye hospital Tianjin, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SHENYANG HE EYE HOSPITAL Shenyang, China, 110034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Daping Hospital, third military medical university Chongqing, China, 400042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Renmin Hosp., Wuhan Univ. Wuhan, China, 430040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Beijing Friendship Hospital,Capital Medical University Beijing, China, 100050 | 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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