PRM-151 in the Prevention of Scarring Following Trabeculectomy

NCT ID: NCT01064817

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-14
• Study Completion Date: 2012-11-14

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

PRM-151

PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)

Group Type: EXPERIMENTAL

PRM-151

Intervention Type: DRUG

PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Interventions

PRM-151

PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Intervention Type: DRUG

Placebo

Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Intervention Type: DRUG

Other Intervention Names

recombinant human serum amyloid P; recombinant human pentraxin 2

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Edelson, MD, FRCPC, MHSc

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

University Hospital Leuven

Leuven, , Belgium

Oftalmologicka klinika Brno-Bohunice

Brno, , Czechia

Facility Hospital Hradec Kralove

Hradec Králové, , Czechia

Palacky University

Olomouc, , Czechia

Hospital Pardubice

Pardubice, , Czechia

Charles University

Prague, , Czechia

Masaryak's Hospital

Ústí nad Labem, , Czechia

UMC St. Radboud West

Nijmegen, , Netherlands

Eramus Medical Center

Rotterdam, , Netherlands

Cheltenham General Hospital

Gloucestershire, , United Kingdom

St. Thomas

London, , United Kingdom

Norfolk and Norwich University Hospital-NHS Trust

Norwich, , United Kingdom

Oxford Eye Hosiptal

Oxford, , United Kingdom

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Countries

Belgium; Czechia; Netherlands; United Kingdom

Other Identifiers

PRM151B-21GL

Identifier Type: OTHER

Identifier Source: secondary_id

2009-017859-98

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GA42405

Identifier Type: -

Identifier Source: org_study_id