Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Conditions
Interventions
Treatment Groups:Treatment Groups: Experimental Group: Anisodine Hydrobromide Tablets + Standard Therapy, administered continuously for 8 weeks
Control Group: Control Group: Placebo + Standard Therapy, administered continuously for 8 weeks
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled in this study. Age: 18-70 years (inclusive), regardless of gender; Diagnosis: Meets diagnostic criteria for non-arteritic anterior ischemic optic neuropathy (NAION); Onset: Current episode = 15 letters (ETDRS chart); Non-study eye: BCVA not worse than the study eye; Binocular involvement: If both eyes affected, the second eye must have onset >= 3 months after the first eye; The second eye must meet all inclusion/exclusion criteria to be enrolled; Washout period: If prohibited medications were used prior to enrollment, required washout periods must be completed (see Section 7.1 for details); Contraception: Subjects of childbearing potential (and their partners) must agree to use effective physical and/or pharmacological contraception from screening until 3 months after trial completion; No plans for pregnancy, sperm donation, or egg donation during the study period; Compliance: Willing to adhere to the trial protocol and voluntarily provide signed informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from this study. Severe ocular comorbidities affecting visual function: Glaucoma, corneal inflammation/opacity, uveitis, significant lens opacity Proliferative diabetic retinopathy, arteritic anterior ischemic optic neuropathy Macular hole, retinal detachment, retinitis pigmentosa, etc. Optic nerve disorders: Any type of optic neuritis Infiltrative, nutritional, hereditary, traumatic, or compressive optic neuropathies Active ocular infection in either eye Bleeding disorders or acute-phase cerebral hemorrhage Severe cardiac conditions: Significant arrhythmias, heart failure (NYHA Class III-IV) Unstable/frequent angina, acute coronary syndrome Recent ocular surgery (within 3 months prior): Corneal refractive surgery, cataract surgery, glaucoma surgery Hepatic/renal impairment: Total bilirubin >1.5×ULN, ALT/AST >1.5×ULN SCr >ULN, ALP >2.5×ULN (ULN = Upper Limit of Normal) Poor glycemic control (HbA1c >= 9%) Uncontrolled hypertension: Resting BP >= 150/90 mmHg despite antihypertensive therapy Active infectious diseases: Hepatitis B, syphilis, HIV, tuberculosis, etc. Severe systemic diseases: Malignancies, organ failure, coagulation disorders Conditions interfering with study treatment Hypersensitivity: Known allergy to trial drug/excipients History of severe drug reactions Neuropsychiatric conditions affecting compliance Recent trial participation (within 3 months) Pregnancy/lactation or planned pregnancy within 6 months Other conditions deemed unsuitable by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCVA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual field;OCT; | — |
Countries
China
Contacts
Public Contactweishihui
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed