PRM-151, a novel agent, is being developed for potential therapeutic uses to prevent, treat and reduce fibrosis. This study will investigate the ability of PRM-151 to prevent scarring post glaucoma filtration surgery (trabeculectomy). MedDRA version: 15.0 Level: PT Classification code 10018304 Term: Glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Recombinant human Serum Amyloid P
Product Code: PRM-151
Pharmaceutical Form: Solution for injection
INN or Proposed INN: not applicaple
Current Sponsor code: PRM-151
Other descriptive na
Sponsors
Promedior Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women of nonchildbearing potential (WONCBP) aged 18 years and older at screening. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for =1 year (with follicle stimulating hormone [FSH] =38 mIU/mL) and must have a negative pregnancy test result at screening. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound. Sexually active men must agree to use a medically acceptable form of contraception during the study. 2. Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or pseudophakic, with visual field or optic disc changes characteristic of glaucoma. For pseudophakic glaucoma patients, the cataract surgery performed was with phacoemulsification and through a corneal incision. 3. Suitable candidate for trabeculectomy in the study eye which the physician deems as medically necessary. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Diagnosis of glaucoma other than chronic angle-closure glaucoma or open-angle glaucoma (ie., uveitic, traumatic or neovascular glaucoma). 2. Any previous ocular surgeries in the study eye involving the upper conjunctiva and sclera. 3. History of laser surgeries in the study eye within 90 days before day 1. 4. Presence or history of any disease that could affect wound healing. 5. Any asymmetric abnormality of the anterior segment which requires additional intervention (surgery or medication). 6. Any abnormality other than glaucoma in the study eye that could affect tonometry. 7. Presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day 1. 8. Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study. 9. Clear corneal phacoemulsification performed within 90 days before day 1. 10. Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 11. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article or the assessment of the effect of the test article. 12. History of drug abuse or alcohol abuse within 1 year before screening that may interfere with the subject’s ability to comply with the protocol requirements. 13. Conjunctival scarring precluding a trabeculectomy. 14. Vitreous in the anterior chamber. 15. Proliferative retinopathy. 16. Abnormality preventing reliable applanation tonometry in each eye. 17. History of drug anaphylaxis to any of the test articles used in this study. 18. Hemodialysis. 19. Use of any anti-scarring ophthalmologic agents within 90 days before day 1. 20. Use of antimetabolites or systemic steroids within 90 days before day 1. 21. Treatment with cancer chemotherapy within 30 days before day 1. 22. Use of any investigational drug within 30 days before day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety and tolerability of PRM-151 administered as a subconjunctival injection in glaucoma patients who have undergone primary trabeculectomy.;Secondary Objective: The secondary objective is to explore the activity of PRM-151 compared to placebo on the success of trabeculectomy by reducing post-surgical scarring in glaucoma patients who have undergone primary trabeculectomy.;Primary end point(s): The exploratory endpoints will be summarized statistically for the ITT population as well as the per-protocol population. Categorical entpoints will be summarized using counts and percentages. Continuous or ordinal data will be summarized using descriptive statistics. Several endpoints will be evaluated to assess the prevention of postoperative scarring. - Successfull IOP control at day 120 - Change from baseline IOP - Percent change from baseline IOP - Bleb scarring as assessed by OCT - Parameters of Moorfields bleb grading scale - Trabeculectomy failure rate - Number of IOP-lowering medications taken per subject;Timepoint(s) of evaluation of this end point: Day 120, Day 180, Day 360 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none - all endpoints are exploratory;Timepoint(s) of evaluation of this end point: none | — |
Countries
Belgium, Czech Republic, Netherlands, United Kingdom
Contacts
Public ContactCRO
Appletree AG
Outcome results
None listed