The effect and the safety with0.1% bromfenac sodium hydrate ophthalmic solution and 0.1% betamethasone sodium phosphate ophthalmic solution in patients with diabetic macular edema.

Clinical research of the effect and the safety with 0.1% bromfenac sodium hydrate ophthalmic solution and 0.1% betamethasone sodium phosphate ophthalmic, otic and nasal solution in patients with diabetic macular edema.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031180308

Enrollment

Registered

2019-03-15

Start date

2017-06-19

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

Assignment of subjects to 0.1% bromfenac sodium hydrate ophthalmic solution and 0.1% betamethasone sodium phosphate ophthalmic, otic and nasal solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Written informed consent 2)Patients with diabetic macular edema 3)Patients with HbA1c value less than 10% 4)Patients with visual acuity more than 0.5 5)Patients with 250-500 micrometer of central macular thickness

Exclusion criteria

Exclusion criteria: 1)Patients with severe diabetic retinopathy or diabetic macular edema who need IVT injection of VEGF inhibitor, retinal photocoagulation, or vitreous surgery 2)Patients with a history of hypersensitivity against components of test drugs 3)Patients with retinochoroidal disease except for diabetic retinopathy or diabetic macular edema 4)Patients with uveitis 5)Patients with glaucoma 6)Patients with previous vitreous surgery 7)Patients who received retinal photocoagulation or cataract surgery within 6 months before starting administration of test drugs 8)Patients who received systemic or topical administration of steroid, IVT injection of VEGF inhibitor within 1 month, or hyperbaric oxygen therapy within 6 months before starting administration of test drugs 9)Patients with excessive myopia less than -6D 10)Patients with a history of hypersensitivity against fluorescein for fluorescent fundus angiography 11)Patients unable to tolerate OCT measurement 12)Patients with cancer, severe hepatopathy ,nephropathy, cardiovascular disease, or endocrine system disease, who was judged to be inappropriate as a subject by doctor in charge 13)Pregnant, lactating, or possible pregnant women 14)Complete loss of ELM or IS/OS line in macular OCT tomography with the eye for effect evaluation 15)Patients with subretinal fluid in macular OCT tomography 16)Patients who has cloudy cyst with possible influence to improvement of visual acuity in macular OCT tomography 17)Patients who was judged to be inappropriate as a subject by doctor

Design outcomes

Primary

Measure	Time frame
The change value of the central macular thickness at 12 weeks after starting administration of test drug from that at the day of starting administration	—

Secondary

Measure	Time frame
The change value, change rate, and actual value of the central macular thickness The change value, actual value, and achievement ratio of corrected visual acuity by ETDRS method Incidence of adverse event	—

Contacts

Public ContactShigehiko Kitano

Tokyo Women`s Medical University Hospital

ge2s-ktn@asahi-net.or.jp+81-333538111

Outcome results

None listed

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