Evaluation of morphological-based treatment regimen of aflibercept in patients with diabetic macular edema

Evaluation of morphological-based treatment regimen of aflibercept in patients with diabetic macular edema - Morphological-based aflibercept treatment for DME

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000025490

Enrollment

Registered

2017-01-01

Start date

2017-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with diabetic macular edema with central macular thickness more than 400 micrometer and best corrected visual acuity between logMAR 0.15 and 1.2

Exclusion criteria

Exclusion criteria: Vitrectomized eye Previous anti-VEGF therapy Previous any treatment for DME before 90 days Pregnant or potentially pregnant Uncontrolled general condition Ocular inflammation Active proliferative diabetic retinopathy

Design outcomes

Primary

Measure	Time frame
Improvement of logMAR visual acuity at 12 months	—

Secondary

Measure	Time frame
Ratio of patients who gained VA >logMAR0.2 at 12 months Dynamic change of central macular thicknes (CMT) during the clinical course of 12 months The requied number of initial contiuous injections of aflibercept to obtain CMT <300 micrometer	—

Countries

Japan

Contacts

Public ContactMasahiko Shimura

Tokyo Medical University, Hachioji Medical Center Depatment of Ophthalmology

masahiko@v101.vaio.ne.jp0426655611

Outcome results