A Phase 1 Dose Escalation Safety Study of PBI-671 in Subjects with Glaucoma with Advanced Vision Loss
Phase 1
- Conditions
- GlaucomaEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12624000785505
- Lead Sponsor
- Perceive Pharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 13
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety[Adverse events (eg--change in intraocular pressure (IOP), changes in retina health) will be assessed on OCT, ocular exam exam, visual acuity, color fundus exam, and intraocular pressure measurement. Adverse events will be assessed at Day 7, 14, Week 4, 8, 12, and 18 after treatment];Change from baseline in slit lamp assessments[Slit lamp exam Day 7, 14, Week 4, 8, 12, and 18 after treatment. (Note that Baseline assessment will also be conducted prior to treatment.)];Change from baseline in blood labs.[Laboratory analysis of blood samples 18 weeks after treatment. (Note that Baseline assessment will also be conducted prior to treatment.)]
- Secondary Outcome Measures
Name Time Method Bioanalysis of soluble drug in aqueous humor[Anterior chamber paracentesis Day 7, Week 4, Week 12, and Week 18 after treatment]