Phase IIa study (doctor-led trial) for the efficacy and safety of SJP-0008 in central retinal artery occlusion

JRCT ID: jRCT2021190013

Registered date:11/12/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: central retinal artery occlusion
• Date of first enrollment: 08/01/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Randomly assigned SJP-0008 100 mg / day (100 mg test drug and 1 placebo tablet) or 200 mg / day (100 mg test drug 2 tablets) once daily after breakfast for up to 29 days .

Outcome(s)

• Primary Outcome: Change in ETDRS visual acuity at the end of the observation period

Secondary Outcome

Change in ETDRS visual acuity in both eyes: Changes in ETDRS visual acuity values, changes, etc. in both eyes at screening, 1 week, 2 weeks, 4 weeks,8 weeks and 12 weeks after starting study drug administration, excluding the primary endpoint.
Improvement and deterioration of ETDRS vision in both eyes: At the time of screening, the percentage of subjects with improved EDTRS visual acuity at 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks after the start of study drug administration was improved by 5 characters, 10 characters, 15 characters or more, and subjects who deteriorated by 15 characters or more Percentage.
Retinal visibility, central vision in target eye: At screening, the foveal threshold in the central 10-2 program in the Humphrey visual field test at 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks after the start of study drug administration, the average value of the central 4 points, the average value of the central 12 points, Mean deviation Value (MD value) and transition of retinal visual sensitivity of Microperimeter MP-3.
Fluorescein angiography in target eye: At screening, the presence or absence of arterial occlusion / stenosis 2 days(only available subjects), 1 week, 4 weeks after the start of study drug administration (presence of inflow delay, presence of reperfusion)
Laser speckle blood flow test in both eyes: At screening, 2 days after the start of study drug administration, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and at study discontinuation, the presence or absence of arterial occlusion, presence or absence of reperfusion, retinal flow volume : RFV)
Optical coherence tomography (OCT) in both eyes :Changes in retinal shape, etc. at screening, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks after the start of study drug administration and at study discontinuation,

Key inclusion & exclusion criteria

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

Include criteria

(1) Age 20 years or older at the time consent was obtained
(2) Written consent for joining the sutudy was available
(3) The onset of nonarteritic retinal artery occlusion (central retinal artery occlusion) occurred expected to start study drug administration within 3 to 48 hours before joining the study
(4) Decimal visual acuity in the included eye better than hand motion and worse than 0.1 in a screening test
(5)All of the following in the screening test before the study
Hemoglobin amount >= 10 g / dL
White blood cell count>= 2,000 / uL
Platelet count >=100,000 / uL
AST =< 50 IU / L
ALT =< 50 IU / L
Total bilirubin =< 1.5 mg / dL
Creatinine =< 1.5 mg / dL
Calcium >=7.5mg / dL, =< 10.5mg / dL

Exclude criteria

(1) Presence of vision-affecting disease in the included eye at risk of progression during the trial, including diabetic retinopathy, retinal detachment, macular disease, or retinitis pigmentosa. However, such patients were included if the primary or other physician deemed inclusion unlikely to affect the safety of the patient.
(2) History of internal eye surgery (including laser treatment) within 90 days before enrollment
(3) Patients with less than 0.1 visual acuity
(4) From the time of obtaining consent to the end of the study drug administration period, patients who are not willing to perform appropriate contraception using effective contraceptive methods (eg condoms, intrauterine devices, oral contraceptives), pregnant women or lactating women
(5) Patients undergoing unapproved or off-label treatment in other clinical trials within 4 weeks before the time consent was obtained
(6)Patients who received the study drug in the past
(7) Patients with poor control of co-morbidity
(8) A judgement that inclusion was inappropriate by the primary or other physician for any other reason

Related Information

• Primary Sponsor: Nakazawa Toru
• Source(s) of Monetary Support: AMED