Phase 1/2 clinical trial to evaluate the safety and efficacy of daily intravitreal injections of KUS121 for three days in patients with non-arteritic central retinal artery occlusio
- Conditions
- non-arteritic central retinal artery occlusion
- Registration Number
- JPRN-UMIN000023979
- Lead Sponsor
- Kyoto University Hospital Institute for Advancement of Clinical and Translational Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9
Not provided
1) Patients who reported one or more of the following conditions: severe complications from cardiac, hepatic, or renal disease; poorly controlled diabetes mellitus 2) Eyes with the following conditions: Acute ocular or periocular infection Uncontrolled intra ocular pressure despite medication Retinal venous occlusion Abnormality in the macula Opacity in the lens or the vitreous such that the fundus is not visible 3) Contralateral eye: BCVA <= 0.1, or visual field loss >= 1/2 of isopter I4e 4) Bilateral onset of CRAO 5) Systemic use of immunosuppressant or steroid medications 6) Participation in other studies during the period 16 weeks prior 7) Possibility or history of hypersensitivity reaction to fluorescein. 8) Inability to understand consent requirements, or unwillingness or inability to participate in all of the follow-up examinations 9) Decision by the principal investigator or the physician in charge that patient was unsuitable for participation in the present study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: adverse events and side effects
- Secondary Outcome Measures
Name Time Method adverse events related to the procedure of intravitreal injection pharmacokinetics visual acuity visula field Sensitivity of the retina electroretinography retinal thickness