Clinical trial NCT01783886: Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema
Keywords: Diabetic Macular Edema
DME
VEGF Trap-Eye
best-corrected visual acuity (BCVA)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2013-02-05
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Baseline up to week 52
Secondary outcomes:
measure: Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
timeFrame: Baseline up to week 52
measure: Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
timeFrame: Baseline up to week 52
measure: 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 - LOCF
timeFrame: Baseline up to week 52
measure: Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF
timeFrame: Baseline up to week 52
measure: Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF
timeFrame: Baseline up to week 52
measure: Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF
timeFrame: Baseline up to week 52
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Wuhan
country: China
state: Hubei
city: Changsha
country: China
state: Hunan
city: Shenyang
country: China
state: Liaoning
city: Xi'an
country: China
state: Shaanxi
city: Qingdao
country: China
state: Shandong
city: Chengdu
country: China
state: Sichuan
city: Hangzhou
country: China
state: Zhejiang
city: Wenzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Hong Kong
country: Hong Kong
city: Kowloon
country: Hong Kong
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Chen YX, Li XX, Yoon YH, Sun X, Astakhov Y, Xu G, Wang H, Ren X, Asmus F; VIVID-East investigators. Intravitreal Aflibercept versus Laser Photocoagulation in Asian Patients with Diabetic Macular Edema: The VIVID-East Study. Clin Ophthalmol. 2020 Mar 9;14:741-750. doi: 10.2147/OPTH.S235267. eCollection 2020.
citation: Ming J, Zhang Y, Xu X, Zhao M, Wang Y, Chen Y, Zhang F, Wang J, Liu J, Zhao X, Han R, Hu S. Cost-effectiveness analysis of intravitreal aflibercept in the treatment of diabetic macular edema in China. J Comp Eff Res. 2020 Feb;9(3):161-175. doi: 10.2217/cer-2019-0174. Epub 2020 Jan 6.