PRM-151 in the Prevention of Scarring Following Trabeculectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Promedior, Inc.
ClinicalTrials.gov Identifier:
NCT01064817
First received: February 5, 2010
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Glaucoma
Drug: PRM-151
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Promedior, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ 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 ] [ Designated as safety issue: Yes ]
    The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields


Other Outcome Measures:
  • Successful Intra-ocular Pressure (IOP) Control [ Time Frame: Day 120 ] [ Designated as safety issue: No ]
    Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP

  • Bleb Scarring [ Time Frame: Day 120 ] [ Designated as safety issue: No ]
    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.


Enrollment: 124
Study Start Date: June 2010
Study Completion Date: November 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
Drug: Placebo
Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064817

Locations
Belgium
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
Netherlands
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.
Investigators
Study Director: Jeffrey Edelson, MD FRCPC MHSc Promedior, Inc.
  More Information

No publications provided

Responsible Party: Promedior, Inc.
ClinicalTrials.gov Identifier: NCT01064817     History of Changes
Other Study ID Numbers: PRM151B-21GL
Study First Received: February 5, 2010
Results First Received: April 14, 2014
Last Updated: July 14, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Promedior, Inc.:
glaucoma, trabeculectomy

Additional relevant MeSH terms:
Cicatrix
Glaucoma
Fibrosis
Pathologic Processes
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 25, 2014