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

Not Applicable

• Conditions: Diabetic macular edema

• Registration Number: JPRN-UMIN000026201
• Lead Sponsor: Diabetes Center Tokyo Womens Medical University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

On screening (1)Topical 1)Patients with severe diabetic retinopathy or DME 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 DME 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 (2)Systemic 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 woman On screening and baseline (1)Topical 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 (3)Other 17)Patients who was judged to be inappropriate as a subject by doctor

Study & Design

• Study Type: Interventional
• Study Design: Not specified