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.
- Conditions
- Diabetic macular edema
- Registration Number
- JPRN-jRCTs031180308
- Lead Sponsor
- Kitano Shigehiko
- Brief Summary
In diabetic macular edema, no significant effect of improving retinal thickness and visual acuity in the bromfenac group was confirmed compared to the betamethasone group. Intraocular pressure increased significantly from baseline in the betamethasone group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method The change value, change rate, and actual value of the central macular thickness<br>The change value, actual value, and achievement ratio of corrected visual acuity by ETDRS method<br>Incidence of adverse event