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Completed

NCT Number: NCT01064817

PRM-151 in the Prevention of Scarring Following Trabeculectomy

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Leuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: recombinant human serum amyloid P, recombinant human pentraxin 2

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-Masked, Placebo-Controlled Study of PRM-151 in the Prevention of Postoperative Scarring in Glaucoma Patients Following Primary Trabeculectomy

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2010
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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