The efficacy of Eylea to treat proliferative diabetic retinopathy/preproliferative diabetic retinopathy in patients with diabetic macular edema

The efficacy of Eylea to treat proliferative diabetic retinopathy/preproliferative diabetic retinopathy in patients with diabetic macular edema - The efficacy of Eylea to treat proliferative diabetic retinopathy/preproliferative diabetic retinopathy in patients with diabetic macular edema

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025234

Enrollment

Registered

2016-12-12

Start date

2017-01-04

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

Aflibercept (Eylea) will be administered by intravitreal injection at a dose of 2 mg (0.05 mL) at intervals of at least 1 month.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with type 1 and 2 diabetes, age > 18 years 2.Proliferative diabetic retinopathy (PDR)/Preproliferative diabetic retinopathy (PPDR) with DME 3.Visual impairment due to DME 4.Central subfield thickness(CST) > 300 microns 5.Decimal visual acuity 0.1-0.7 6.Patients who have given informed consent

Exclusion criteria

Exclusion criteria: 1.Patient with neovascularization of the optic disc (NVD) 2.Eyes requiring immediate vitrectomy for reasons such as rhegmatogenous or traction retinal detachment 3.Patient with 2 or more NVE 4.Patient with non-perfusion area detected by FA (NPA, >10 disc diameter) 5.History of vitreoretinal surgery 6.History of laser photocoagulation within 3 months before study entry 7.History of intravitreal or peribulber corticosteroids within 3 months before study entry 8.History of ocular surgery within 3 months before study entry 9.History of anti-VEGF injection 10.HbA1c >12% 11.Patient who is judged inappropriate for study

Design outcomes

Primary

Measure	Time frame
Change in Best-corrected visual acuity (BCVA) from baseline to month 12	—

Secondary

Measure	Time frame
1. BCVA at every visit 2. Change of CST at every visit 3. Evaluation of microaneurysm (MA) by OCT angiography at macula at every visit 4. Non perfusion area(NPA), Neovascularization elsewhere(NVE) and Neovascularization of disc(NVD) by FA at pretreatment and 12 month 5. Glycosylated hemoglobin levels (HbA1c) at every visit 6. Diabetic retinopathy severity scale (DRSS) at baseline, month 6 and 12 7. Intraocular pressure(IOP) at every visit 8. Fundus photograph at every visit	—

Measure

Time frame

1. BCVA at every visit 2. Change of CST at every visit 3. Evaluation of microaneurysm (MA) by OCT angiography at macula at every visit 4. Non perfusion area(NPA), Neovascularization elsewhere(NVE) and Neovascularization of disc(NVD) by FA at pretreatment and 12 month 5. Glycosylated hemoglobin levels (HbA1c) at every visit 6. Diabetic retinopathy severity scale (DRSS) at baseline, month 6 and 12 7. Intraocular pressure(IOP) at every visit 8. Fundus photograph at every visit

—

Countries

Japan

Contacts

Public ContactYuji Ito

Kyorin University School of Medicine Kyorin Eye Center

itoyuji@eye-center.org0422-47-5511

Outcome results

None listed

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