Phase II study of Efficacy and Safety of SJE-2079 in the Treatment for Diabetic Macular Edema

Phase II study of Efficacy and Safety of SJE-2079 in the Treatment for Diabetic Macular Edema - Efficacy and Safety of SJE-2079 for Diabetic Macular Edema

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011873

Enrollment

Registered

2013-09-26

Start date

2013-09-26

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 (DME)

Interventions

SJE-2079 BID group: One drop of SJE-2079 instilled in the affected eye(s) twice a day, and 1 drop of vehicle instilled in the same eye(s) twice a day. SJE-2079 QID group: One drop of SJE-2079 instille

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Diabetic macular edema for study eyes 2)Best corrected visual acuity in the efficacy evaluation-intended eye of 30-80 EDTRS letters 3)OCT retinal thickness at center point in the efficacy evaluation-intended eye of 250-600 microns

Exclusion criteria

Exclusion criteria: 1)Active and serious retinal disease 2)History of steroid-induced elevation of IOP 3)Any active ocular disease other than diabetic retinopathy

Design outcomes

Primary

Measure	Time frame
Mean change from baseline in retinal central foveal thickness using optical coherence tomography (OCT)	—

Countries

Japan

Contacts

Public ContactYoko Minagawa

Senju Pharmaceutical co.,ltd. Strategic Development Group, Regulatory Science Div.

yoko_minagawa@senju.co.jp06-6201-9605

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026