Phase 2
N=124
PRM-151 in the Prevention of Scarring Following Trabeculectomy
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01064817 ↗Enrolled (actual)
124
Serious AEs
12.1%
Results posted
Aug 2014
Primary outcome: Primary: Safety of Subconjunctival Injection — 274; 220; 166; 113 Number of occurrences
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PRM-151 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Subconjunctival Injection |
274; 220; 166; 113; 16; 11 | — |
| PRIMARY Subjects With Safety Related Events or Findings |
46; 47; 44; 41; 9; 6 | — |
Summary
This study will assess the safety and tolerability of PRM-151 administered as a subconjunctival injection and explore the effect of PRM-151 on various correlates of the wound healing process that occurs in the eye after glaucoma filtration surgery.
Eligibility Criteria
Inclusion Criteria
- Men or women of nonchildbearing potential (WONCBP) aged 18 years and older at screening.
- 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.
- Suitable candidate for trabeculectomy in the study eye which the physician deems as medically necessary.
Exclusion Criteria
- Diagnosis of glaucoma other than chronic angle-closure glaucoma or open-angle glaucoma (ie., uveitic, traumatic or neovascular glaucoma).
- Any previous ocular surgeries in the study eye involving the upper conjunctiva and sclera.
- History of laser surgeries in the study eye within 90 days before day 1.
- Presence or history of any disease that could affect wound healing.
- Any asymmetric abnormality of the anterior segment which requires additional intervention (surgery or medication).
- Any abnormality other than glaucoma in the study eye that could affect tonometry.
- Presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day 1.
- Clear corneal phacoemulsification performed within 90 days before day 1.
Data sourced from ClinicalTrials.gov (NCT01064817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.