PRM-151 Trabeculectomy Scarring Prevention v.1
Research type
Research Study
Full title
A Randomized, Double-Masked, Placebo-Controlled Study of PRM-151 in the Prevention of Postoperative Scarring in Glaucoma Patients Following Primary Trabeculectomy
IRAS ID
44576
Contact name
David Charles Broadway
Sponsor organisation
Promedior Inc
Eudract number
2009-017859-98
Clinicaltrials.gov Identifier
Research summary
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 an 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. PRM-151 is expected to reduce (or modulate) wound healing and prevent excessive scarring which may cause trabeculectomy failure. The study will be conducted in patients suffering from glaucoma who are due to undergo trabeculectomy. Patients will be randomised to have either PRM-151 or placebo. The aim of the study is to determine whether administration of PRM-151 improves the success of trabeculectomy and/or reduces complications. The study will take place in the UK, the Netherlands and in Czech Republic (in approximately 15 ophthalmic hospitals) and involve 130 patients for approximately 1.5 years.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
10/H0904/11
Date of REC Opinion
17 May 2010
REC opinion
Further Information Favourable Opinion