Clinical trial NCT01064817: PRM-151 in the Prevention of Scarring Following Trabeculectomy
Official title: A Randomized, Double-Masked, Placebo-Controlled Study of PRM-151 in the Prevention of Postoperative Scarring in Glaucoma Patients Following Primary Trabeculectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Keywords: glaucoma, trabeculectomy
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Glaucoma is a disease of the eye which affects the optic nerve (the nerve that sends signals from the eye to the brain) and is associated with visual field defects and potential blindness. The treatment of glaucoma involves lowering the pressure in the eye, which is often (but not always) elevated due to accumulation of fluid inside the eye that cannot drain away. In the operation called trabeculectomy (a type of filtration surgery), a small channel is created through the sclera (the white of the eye) to allow accumulated fluid to drain away. Scarring may occur after surgery when, during healing, too much collagen (a type of protein) is deposited in the channel. This causes the channel to seal up and the pressure inside the eye to build up again.

The study will be conducted in patients suffering from glaucoma who are due to undergo trabeculectomy. Patients will be randomized to have either PRM-151 or placebo.

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.

Primary outcomes:
measure: Safety of Subconjunctival Injection
timeFrame: AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30
measure: Subjects With Safety Related Events or Findings
timeFrame: First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs
Secondary outcomes:
Other outcomes:
measure: Successful Intra-ocular Pressure (IOP) Control
timeFrame: Day 120
measure: Bleb Scarring
timeFrame: Day 120
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Brno
country: Czechia
facility: Oftalmologicka klinika Brno-Bohunice
city: Hradec Kralove
country: Czechia
facility: Facility Hospital Hradec Kralove
city: Olomouc
country: Czechia
facility: Palacky University
city: Pardubice
country: Czechia
facility: Hospital Pardubice
city: Praha
country: Czechia
facility: Charles University
city: Usti' Nad/Labem
country: Czechia
facility: Masaryak's Hospital
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud West
city: Rotterdam
country: Netherlands
facility: Eramus Medical Center
city: Gloucestershire
country: United Kingdom
facility: Cheltenham General Hospital
city: London
country: United Kingdom
facility: St. Thomas
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital-NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford Eye Hosiptal
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Jeffrey Edelson, MD, FRCPC, MHSc
role: STUDY_DIRECTOR
References: