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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.

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.

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Since written consent was withdrawn in 1 case immediately after registration, data with 10 cases in the bromfenac group (male: 9, female: 1) and 9 cases in the betamethasone group (male: 8, female: 1) were used for analysis. The age was 65.9 +/- 8.2 years in the bromfenac group and 67.4 +/- 12.4 years in the betamethasone group. The central retinal thickness was 302.8 +/- 34.5 micrometre in the bromfenac group, 340.9 +/- 66.1 micrometre in the betamethasone group, and the visual acuity was 76.5 +/- 8.3 characters in the bromfenac group and 68.1 +/-9.4 characters in the betamethasone group. No difference was observed between the drug groups in any of the items. (All data are mean +/- SD)

The registration of the first case and final case were in June 2017 and in October 2019, respectively, which took about two and a half years as the registration period. The enrollment pace was slower than initially predicted, as fewer patients met the selection criteria than expected. Written consent was withdrawn after screening in 1 case, administration was discontinued due to side effects (4 weeks after administration) in 1 case, and administration was completed in 12 weeks in 18 cases.

The adverse events during the study period was 3 cases, 1 case of subretinal fluid, 1 case of increased intraocular pressure, and 1 case of vitreous hemorrhage, all of the events were non-serious.

The change of retinal thickness from baseline at 12 weeks after administration was -5.6 +/- 25.4 micrometre in the bromfenac group and -0.3 +/- 26.8 micrometre in the betamethasone group, confirming no significant difference between the groups (p = 0.681). Also no significant difference was confirmed between the groups in the change value at the observation time point other than 12 weeks, the rate of change and the measured values at each observation time. Regarding visual acuity, no significant difference was confirmed between the groups in the change value at each observation point. As for the intraocular pressure value, a significant increase in intraocular pressure was confirmed in the betamethasone group 8 and 12 weeks after administration compared to the baseline value, but no change in intraocular pressure was confirmed in the bromfenac group.

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.

Oct. 28, 2021

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs031180308

Kitano Shigehiko

Tokyo Women`s Medical University Hospital

8-1 Kawada-cho, Shinjuku-ku, Tokyo

ge2s-ktn@asahi-net.or.jp

Kitano Shigehiko

Tokyo Women`s Medical University Hospital

8-1 Kawada-cho, Shinjuku-ku, Tokyo

+81-333538111

ge2s-ktn@asahi-net.or.jp

Complete

Feb. 24, 2017

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

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

Both

Diabetic macular edema

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

043

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

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

+81-3-3202-7181

Feb. 26, 2019

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