Disease registry for central retinal artery occlusion

JRCT ID: jRCT1020190019

Registered date:28/01/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: central retinal artery occlusion
• Date of first enrollment: 10/07/2020
• Target sample size: 30
• Study type: Observational

Outcome(s)

• Primary Outcome: Change in ETDRS visual acuity three months after onset
• 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 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 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, 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 1 week, 2 weeks, 4 weeks after the start of study (presence of inflow delay, presence of reperfusion) Laser speckle blood flow test in both eyes: At screening, 2 days after the start of study, 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, relative 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 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 study was available (3) The onset of nonarteritic retinal artery occlusio n (central retinal artery occlusion) occurred expec ted 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 scree ning test

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) Patients undergoing unapproved or off-label treatment in other clinical trials (corporate clinical trials, physician-led clinical trials, and extended clinical trials), or advanced medicine and specified clinical research
(5) Patients with poor control of co-morbidity
(6) A judgement that inclusion was inappropriate by the primary or other physician for any other reason.

Related Information

• Primary Sponsor: Tsuda Satoru
• Source(s) of Monetary Support: Senju Pharmaceutical Co.,Ltd.,AMED