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.

JRCT ID: jRCTs031180308

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetic macular edema
• Date of first enrollment: 19/06/2017
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Assignment of subjects to 0.1% bromfenac sodium hydrate ophthalmic solution and 0.1% betamethasone sodium phosphate ophthalmic, otic and nasal solution

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kitano Shigehiko
• Source(s) of Monetary Support: Senju pharmaceutical Co., LTD.