None listed
Conditions
Brief summary
This is a prospective, open-label, multi-center Phase 1 study to evaluate the safety and tolerability of a single, unilateral intravitreal injection of escalating doses of PBI-671 Gel for Injection (PBI-671) in subjects with advanced glaucoma). Phase 1 follows a standard dose escalation model with two doses to determine the Maximum Tolerated Dose (MTD) of PBI-671 and recommended Phase 2 dose (RP2D). An Extension Cohort of up to 7 subjects dosed at less than or equal to the MTD may also be enrolled in the Phase 1 study, if the Sponsor and Safety Review Committee (SRC) elect to add additional subjects to further characterize dose levels.
Interventions
A single intravitreal dose of either Dose A or Dose B of PBI-671 in one eye by an ophthalmologist. Dose A will be 0.4 mg/eye, Dose B will be 1.0 mg/eye. The first 3 subjects will receive Dose A (with sentinel dosing), the second 3 subjects will receive Dose B (with sentinel dosing). The remaining 7 subjects may be allocated between Doses A and B as per the recommendation of the Safety Review Committee.
Study sites are to follow ophthalmic standards for intravitreal injection preparation and pro
A single intravitreal dose of either Dose A or Dose B of PBI-671 in one eye by an ophthalmologist. Dose A will be 0.4 mg/eye, Dose B will be 1.0 mg/eye. The first 3 subjects will receive Dose A (with sentinel dosing), the second 3 subjects will receive Dose B (with sentinel dosing). The remaining 7 subjects may be allocated between Doses A and B as per the recommendation of the Safety Review Committee. Study sites are to follow ophthalmic standards for intravitreal injection preparation and procedure, Ophthalmolost will apply single-use topical anesthetic to the study eye as needed to achieve adequate anesthesia for the procedure. Additional local subconjunctival anesthesia (e.g., 1% lidocaine hydrochloride solution) can be used at the Investigator’s discretion.
Sponsors
Perceive Pharma, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible subjects will have been diagnosed with glaucoma with advanced vision loss with the following characteristics: 1) Has substantial vision loss, but retains the ability to fixate for SD-OCT acquisition in at least the study eye. 2) Is unlikely to substantially benefit from an additional, commercially approved topical medication for glaucoma. 3) Is anticipated to remain on stable ocular drug therapy (other than the study drug), including IOP-lowering therapy (as needed), without surgery during the course of the study.
Exclusion criteria
Confounding ophthalmic and systemic diseases, medications, or therapies. Allergy to study drug or excipient.
Outcome results
None listed