PRM-151 in the Prevention of Scarring Following Trabeculectomy

Phase 2

Completed

• Conditions: Glaucoma
• Interventions: Drug: PRM-151; Drug: Placebo

• Registration Number: NCT01064817
• Lead Sponsor: Hoffmann-La Roche

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.

Study Timeline

• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Study Start: 2010-06-14
• Primary Completion: 2012-04-30
• Study Completion: 2012-11-14
• Results First Submitted: 2014-04-14
• Results First Submitted QC: 2014-07-14
• Results First Posted: 2014-08-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRM-151	PRM-151	PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety of Subconjunctival Injection	AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30	Number of adverse events (AEs), treatment emergent adverse events (TEAEs), non-ocular TEAEs, Ocular TEAEs, serious adverse events (SAEs), abnormal slit-lamp biomicroscopic findings, and abnormal dilated fundoscopy findings
Subjects With Safety Related Events or Findings	First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs	The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields

Trial Locations

Locations (14)

UMC St. Radboud West; 🇳🇱 Nijmegen, Netherlands

Oxford Eye Hosiptal; 🇬🇧 Oxford, United Kingdom

St. Thomas; 🇬🇧 London, United Kingdom

Cheltenham General Hospital; 🇬🇧 Gloucestershire, United Kingdom

Facility Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia

Oftalmologicka klinika Brno-Bohunice; 🇨🇿 Brno, Czechia

Hospital Pardubice; 🇨🇿 Pardubice, Czechia

Norfolk and Norwich University Hospital-NHS Trust; 🇬🇧 Norwich, United Kingdom

Royal Hallamshire Hospital; 🇬🇧 Sheffield, United Kingdom

Palacky University; 🇨🇿 Olomouc, Czechia

University Hospital Leuven; 🇧🇪 Leuven, Belgium

Masaryak's Hospital; 🇨🇿 Usti' Nad/Labem, Czechia

Charles University; 🇨🇿 Praha, Czechia

Eramus Medical Center; 🇳🇱 Rotterdam, Netherlands