Exploratory clinical study to examine the efficacy of the simultaneous subthreshold retinal-photocoagulation and the intravitreal injection of VEGF inhibitors for diabetic macular edema

Exploratory clinical study to examine the efficacy of the simultaneous subthreshold retinal-photocoagulation and the intravitreal injection of VEGF inhibitors for diabetic macular edema - Simultaneous subthreshold retinal-photocoagulation and intravitreal injection of VEGFinhibitors for DME

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019635

Enrollment

Registered

2015-11-09

Start date

2015-12-01

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

intravitreal injection of VEGF inhibitors intravitreal injection of VEGF inhibitors subthreshold retinal-photocoagulation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Japanese male and female >= 18 years with type 1 or 2 diabetes mellitus 2) DME with central involvementin the study eye 3) Decrease in vision determined to be primarily the result of DME in the study eye 4) central macular thickness >= 300um in the study eye 5)BCVA of 0.7 to 0.05 in the study eye

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
A period before re-injection : A period before re-injection being necessary after the 3 consecutive monthly intravitreal injection of VEGF inhibitors	—

Countries

Japan

Contacts

Public ContactTomoaki Tatsumi

Chiba University Graduate School of Medicine Department of Ophthalmology and Visual Science

ttatsumi@chiba-u.jp043-222-7171

Outcome results

None listed

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