Intravitreal Aflibercept Injection in Vision Impairment Due to DME (VIVID-DME)

Bayer

Status and phase: Completed; Phase 3

Conditions: Macular Edema; Diabetes Mellitus

Treatments: Procedure: Macular Laser Photocoagulation (Control); Biological: VEGF Trap-Eye (BAY86-5321)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01331681

91745

2010-022364-12 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 406 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults ≥ 18 years with type 1 or 2 diabetes mellitus
• Subjects with 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
• BCVA 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, with the exception of inactive, regressed PDR
• Uncontrolled diabetes mellitus, as defined by HbA1c > 12%
• Only 1 functional eye even if that eye is otherwise eligible for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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406 participants in 3 patient groups

Intravitreal Aflibercept Injection 2Q4

Experimental group

Description:

Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).

Treatment:

Biological: VEGF Trap-Eye (BAY86-5321)

Biological: VEGF Trap-Eye (BAY86-5321)

Intravitreal Aflibercept Injection 2Q8

Experimental group

Description:

Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).

Treatment:

Biological: VEGF Trap-Eye (BAY86-5321)

Biological: VEGF Trap-Eye (BAY86-5321)

Macular Laser Photocoagulation (Control)

Active Comparator group

Description:

Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.

Treatment:

Procedure: Macular Laser Photocoagulation (Control)