Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema (VISTA DME)

Regeneron Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Diabetic Macular Edema

Treatments

Procedure: Macular Laser Photocoagulation

Drug: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01363440

VGFT-OD-1009

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.

Enrollment

466 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The following is an abbreviated list of inclusion criteria:

Adults ≥ 18 years with type 1 or 2 diabetes mellitus
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

The following is an abbreviated list of exclusion criteria:

Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1
Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1
Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1
Active proliferative diabetic retinopathy (PDR) in the study eye
Uncontrolled diabetes mellitus
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

466 participants in 3 patient groups

Macular Laser Photocoagulation Treatment (Control)

Active Comparator group

Description:

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

Treatment:

Procedure: Macular Laser Photocoagulation

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4

Experimental group

Description:

Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.

Treatment:

Drug: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8

Experimental group

Description:

Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.