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 range40 Years
SexALL
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)
✓. 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;
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