Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement (VIVID EAST)

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Bayer

Status and phase

Completed
Phase 3

Conditions

Macular Edema

Treatments

Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Procedure: Macular Laser Photocoagulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01783886
15161

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

381 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 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

381 participants in 3 patient groups

Intravitreal Aflibercept Injection 2Q4
Experimental group
Description:
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
Treatment:
Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Intravitreal Aflibercept Injection 2Q8
Experimental group
Description:
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
Treatment:
Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Macular Laser Photocoagulation
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 over 48 weeks.
Treatment:
Procedure: Macular Laser Photocoagulation

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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