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PRM-151 in the Prevention of Scarring Following Trabeculectomy

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Glaucoma

Interventions: PRM-151, Placebo

Countries: Belgium, Czechia, Netherlands, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (14)

Leuven, Belgium
Brno, Czechia
Hradec Králové, Czechia
Olomouc, Czechia
Pardubice, Czechia
Prague, Czechia
Ústí nad Labem, Czechia
Nijmegen, Netherlands
Rotterdam, Netherlands
Gloucestershire, United Kingdom
London, United Kingdom
Norwich, United Kingdom
Oxford, United Kingdom
Sheffield, United Kingdom