PRM-151 in the Prevention of Scarring Following Trabeculectomy

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche; Promedior, Inc.
• Treatments: Polystyrene sulfonic acid

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.