DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact (DA VINCI)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Intravitreal Aflibercept Injection; Procedure: Laser Photocoagulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00789477

VGFT-OD-0706

Details and patient eligibility

About

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

Full description

Qualified subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with clinically significant DME with central involvement
• Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema
• ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye

Exclusion criteria

• History of vitreoretinal surgery in the study eye
• Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
• Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening
• Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening
• Uncontrolled diabetes mellitus
• Uncontrolled hypertension defined as systolic > 180mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
• Ocular disorders in the study eye, other than DME, that may confound interpretation of study results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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221 participants in 5 patient groups

Intravitreal Aflibercept Injection .5Q4

Experimental group

Description:

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks

Treatment:

Drug: Intravitreal Aflibercept Injection

Intravitreal Aflibercept Injection 2Q4

Experimental group

Description:

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks

Treatment:

Drug: Intravitreal Aflibercept Injection

Intravitreal Aflibercept Injection 2Q8

Experimental group

Description:

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks

Treatment:

Drug: Intravitreal Aflibercept Injection

Intravitreal Aflibercept Injection 2PRN

Experimental group

Description:

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria

Treatment:

Drug: Intravitreal Aflibercept Injection

Laser Photocoagulation

Active Comparator group

Description:

Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.

Treatment:

Procedure: Laser Photocoagulation