PRM-151 in the Prevention of Scarring Following Trabeculectomy

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064817
• Other study ID #: GA42405
• Secondary ID: PRM151B-21GL2009
• Status: Completed
• Phase: Phase 2
• Start date: June 14, 2010
• Est. completion date: November 14, 2012

Study information

• Verified date: March 2022
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: November 14, 2012
• Est. primary completion date: April 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven
Czechia	Oftalmologicka klinika Brno-Bohunice	Brno
Czechia	Facility Hospital Hradec Kralove	Hradec Kralove
Czechia	Palacky University	Olomouc
Czechia	Hospital Pardubice	Pardubice
Czechia	Charles University	Praha
Czechia	Masaryak's Hospital	Usti' Nad/Labem
Netherlands	UMC St. Radboud West	Nijmegen
Netherlands	Eramus Medical Center	Rotterdam
United Kingdom	Cheltenham General Hospital	Gloucestershire
United Kingdom	St. Thomas	London
United Kingdom	Norfolk and Norwich University Hospital-NHS Trust	Norwich
United Kingdom	Oxford Eye Hosiptal	Oxford
United Kingdom	Royal Hallamshire Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Belgium,  Czechia,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Successful Intra-ocular Pressure (IOP) Control	Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP	Day 120
Other	Bleb Scarring	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.	Day 120
Primary	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
Primary	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