PRM-151 in the Prevention of Scarring Following Trabeculectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01064817
Recruitment Status : Completed
First Posted : February 8, 2010
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Information provided by (Responsible Party):
Promedior, Inc.

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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: PRM-151 Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : June 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma Scars

Arm Intervention/treatment
Experimental: PRM-151
PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)
Drug: PRM-151
PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
Other Names:
  • recombinant human serum amyloid P
  • recombinant human pentraxin 2

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

Primary Outcome Measures :
  1. Safety of Subconjunctival Injection [ Time Frame: 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

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

Other Outcome Measures:
  1. Successful Intra-ocular Pressure (IOP) Control [ Time Frame: Day 120 ]
    Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP

  2. Bleb Scarring [ Time Frame: Day 120 ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01064817

University Hospital Leuven
Leuven, Belgium, B-3000
Czech Republic
Oftalmologicka klinika Brno-Bohunice
Brno, Czech Republic, 639 00
Facility Hospital Hradec Kralove
Hradec Kralove, Czech Republic, 500 05
Palacky University
Olomouc, Czech Republic, 775 20
Hospital Pardubice
Pardubice, Czech Republic, 53203
Charles University
Praha, Czech Republic
Masaryak's Hospital
Usti' Nad/Labem, Czech Republic, 40013
UMC St. Radboud West
Nijmegen, Netherlands, 6525 EX
Eramus Medical Center
Rotterdam, Netherlands, 3015 CE
United Kingdom
Cheltenham General Hospital
Gloucestershire, United Kingdom, GL53 7AN
St. Thomas
London, United Kingdom
Norfolk and Norwich University Hospital-NHS Trust
Norwich, United Kingdom, NR4 7UY
Oxford Eye Hosiptal
Oxford, United Kingdom, OX3 9DU
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Promedior, Inc.
Study Director: Jeffrey Edelson, MD FRCPC MHSc Promedior, Inc.

Responsible Party: Promedior, Inc. Identifier: NCT01064817     History of Changes
Other Study ID Numbers: PRM151B-21GL
First Posted: February 8, 2010    Key Record Dates
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014
Last Verified: July 2014

Keywords provided by Promedior, Inc.:
glaucoma, trabeculectomy

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases