PRM-151 in the Prevention of Scarring Following Trabeculectomy

NCT01064817 | Completed Phase 2 Results DMC

• 3 other identifiers: GA42405PRM151B-21GL2009-017859-98
• Study Type: interventional
• Target: 124
• Locations: 4 countries
• Sites: 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.

Conditions

Glaucoma

Keywords

glaucoma, trabeculectomy

Outcome Measures

Primary Outcomes (2)

• Safety of Subconjunctival Injection

  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

  AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30

• Subjects With Safety Related Events or Findings

  The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields

  First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs

Other Outcomes (2)

• Successful Intra-ocular Pressure (IOP) Control

  Day 120

• Bleb Scarring

  Day 120

Study Arms (2)

PRM-151

EXPERIMENTAL

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

Drug: PRM-151

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PRM-151 DRUG

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

Also known as: recombinant human serum amyloid P, recombinant human pentraxin 2

PRM-151

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (14)

University Hospital Leuven

Leuven, B-3000, Belgium

Location

Oftalmologicka klinika Brno-Bohunice

Brno, 639 00, Czechia

Location

Facility Hospital Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Palacky University

Olomouc, 775 20, Czechia

Location

Hospital Pardubice

Pardubice, 53203, Czechia

Location

Charles University

Prague, Czechia

Location

Masaryak's Hospital

Ústí nad Labem, 40013, Czechia

Location

UMC St. Radboud West

Nijmegen, 6525 EX, Netherlands

Location

Eramus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Cheltenham General Hospital

Gloucestershire, GL53 7AN, United Kingdom

Location

St. Thomas

London, United Kingdom

Location

Norfolk and Norwich University Hospital-NHS Trust

Norwich, NR4 7UY, United Kingdom

Location

Oxford Eye Hosiptal

Oxford, OX3 9DU, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma

Interventions

PRM-151

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Elizabeth G. Trehu, MD
• Organization: Promedior, Inc.

btrehu@promedior.com

781-538-4203

Study Officials

• Jeffrey Edelson, MD, FRCPC, MHSc

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 8, 2010
• Study Start: June 14, 2010
• Primary Completion: April 30, 2012
• Study Completion: November 14, 2012
• Last Updated: April 28, 2022
• Results First Posted: August 7, 2014

Record last verified: 2022-03

Locations

CZ (6); GB (5); BE (1); NL (2)