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

Phase 2

• Conditions: central retinal artery occlusion; retina artery occlusion; D015356

• Registration Number: JPRN-jRCT2021190013
• Lead Sponsor: akazawa Toru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion 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 / d

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified