Clinical Study of FB1001 in Patients (NCT06506305) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Clinical Study of FB1001 in Patients
China59 participantsStarted 2024-08-15
Plain-language summary
This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single/multiple intravitreal injection of FB1001 in patients with APACG(Acute Primary Angle-Closure Glaucoma) or NAION(Nonarteritic Anterior Ischemic Optic Neuropathy).
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with Acute Primary Angle-Closure Glaucoma (APACG) Optic Neuropathy：
. Within 120 hours prior to the planned administration of the study drug, the study eye has the initial symptoms of an acute attack of primary angle closure; refer to the diagnostic criteria as attached in protocol;
. The symptom duration of the acute attack ≥1 day, and the experienced highest intraocular pressure (IOP) in the study eye ≥30 mmHg;
. After acute attack is controlled, the BCVA in the study eye is 20/40 or higher;
. After successful treatment of the acute attack, the IOP of the study eye \<21 mmHg before dosing.
. Patients with Acute Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SAD phase: DLTs incidence
Timeframe: within 28 days after dosing
2
SAD phase: Incidence of Treatment-Emergent Adverse Events
Timeframe: Baseline to 12 weeks
3
MAD phase: Incidence of Treatment-Emergent Adverse Events
Timeframe: Baseline to 24 weeks
Trial details
NCT IDNCT06506305
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
. Positive diagnosis of NAION with symptom onset within 14 days prior to planned dosing with FB1001, refer to the diagnostic criteria as attached in protocol;
. Before drug administration, the BCVA score in the study eye by ETDRS is better than or equal to 15 letters.
Exclusion criteria
. Patients with Acute Primary Angle-Closure Glaucoma (APACG) Optic Neuropathy:
. History or current diagnosis of glaucoma in both eyes;
. History of chronic primary angle-closure glaucoma in any eye;
. History of secondary angle-closure glaucoma in any eye.
. Patients with Acute Non-arteritic Anterior Ischemic Optic Neuropathy (NAION):Intraocular pressure \>24 mmHg in the study eye;
. History of optic neuritis or uveitis in any eye;
. Clinical evidence of temporal arteritis;
. History of collagen vascular disease or other inflammatory disease, or multiple sclerosis;