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PRM-151 in the Prevention of Scarring Following Trabeculectomy

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PRM-151
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glaucoma focused on measuring glaucoma, trabeculectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Leuven
  • Oftalmologicka klinika Brno-Bohunice
  • Facility Hospital Hradec Kralove
  • Palacky University
  • Hospital Pardubice
  • Charles University
  • Masaryak's Hospital
  • UMC St. Radboud West
  • Eramus Medical Center
  • Cheltenham General Hospital
  • St. Thomas
  • Norfolk and Norwich University Hospital-NHS Trust
  • Oxford Eye Hosiptal
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRM-151

Placebo

Arm Description

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

Placebo

Outcomes

Primary Outcome Measures

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
Subjects With Safety Related Events or Findings
The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields

Secondary Outcome Measures

Full Information

First Posted
February 5, 2010
Last Updated
March 31, 2022
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01064817
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 14, 2010 (Actual)
Primary Completion Date
April 30, 2012 (Actual)
Study Completion Date
November 14, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, trabeculectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRM-151
Arm Type
Experimental
Arm Description
PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
PRM-151
Other Intervention Name(s)
recombinant human serum amyloid P, recombinant human pentraxin 2
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
Primary Outcome Measure Information:
Title
Safety of Subconjunctival Injection
Description
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
Time Frame
AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30
Title
Subjects With Safety Related Events or Findings
Description
The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields
Time Frame
First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs
Other Pre-specified Outcome Measures:
Title
Successful Intra-ocular Pressure (IOP) Control
Description
Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP
Time Frame
Day 120
Title
Bleb Scarring
Description
Exploratory Efficacy Outcome measure: Bleb scarring is graded on a scale from 0-3. 0= none to minimal scarring, 1= mild, 2= moderate, 3= severe scarring.
Time Frame
Day 120

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Edelson, MD, FRCPC, MHSc
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Oftalmologicka klinika Brno-Bohunice
City
Brno
ZIP/Postal Code
639 00
Country
Czechia
Facility Name
Facility Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Palacky University
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Hospital Pardubice
City
Pardubice
ZIP/Postal Code
53203
Country
Czechia
Facility Name
Charles University
City
Praha
Country
Czechia
Facility Name
Masaryak's Hospital
City
Usti' Nad/Labem
ZIP/Postal Code
40013
Country
Czechia
Facility Name
UMC St. Radboud West
City
Nijmegen
ZIP/Postal Code
6525 EX
Country
Netherlands
Facility Name
Eramus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Cheltenham General Hospital
City
Gloucestershire
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
St. Thomas
City
London
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital-NHS Trust
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Oxford Eye Hosiptal
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

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PRM-151 in the Prevention of Scarring Following Trabeculectomy

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