non-arteritic central retinal artery occlusion
Conditions
Interventions
daily intravitreal injections KUS121 25 microgram for 3 days daily intravitreal injections KUS121 50 microgram for 3 days
Sponsors
Kyoto University Hospital Institute for Advancement of Clinical and Translational Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age >= 20 years 2) Non-arteritic central retinal artery occlusion (CRAO) 3) Best-corrected visual acuity (BCVA) <= 0.1 and better than hand motion 4) Laboratory data obtained prior to enrollment meeting the following criteria: Hemoglobin >= 10 g/dL WBC count >= 2,000 /uL Platelet count >= 100000 /uL AST <= 50 IU/L ALT <= 50 IU/L Total bilirubin <= 1.5 mg/dL Creatinine <= 1.5 mg/dL 5) Both men and women reporting the possibility of pregnancy were required to agree to be on contraception from the first injection until 4 weeks after the last injection. 6) Written informed consent of the patient
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: adverse events and side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events related to the procedure of intravitreal injection pharmacokinetics visual acuity visula field Sensitivity of the retina electroretinography retinal thickness | — |
Countries
Japan
Contacts
Public ContactHanako Ikeda
Kyoto University Hospital Institute for Advancement of Clinical and Translational Science
Outcome results
None listed