Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)

Bayer73 enrolled

Overview

This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Macular Edema

Interventions

VEGF Trap-Eye (BAY86-5321)BIOLOGICAL

Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults ≥ 18 years with type 1 or 2 diabetes mellitus * Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye * BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye Exclusion Criteria: * 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

Locations (18)

Unnamed facility

Matsuyama, Ehime, Japan

Unnamed facility

Maebashi, Gunma, Japan

Unnamed facility

Kobe, Hyōgo, Japan

Outcomes

Primary Outcomes

Adverse Event collection

Time frame: Week 52

Secondary Outcomes

Change from baseline in BCVA (best corrected visual acuity) letter score

Time frame: Week 52

Data from ClinicalTrials.gov

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