PRM-151 in the Prevention of Scarring Following Trabeculectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: PRM-151
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRM-151<br>PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) | Drug: PRM-151<br>* PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9<br>* Other names: recombinant human pentraxin 2;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, trabeculectomy