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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
124
University Hospital Leuven
Leuven, Belgium
Oftalmologicka klinika Brno-Bohunice
Brno, Czechia
Facility Hospital Hradec Kralove
Hradec Králové, Czechia
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
Time frame: 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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Palacky University
Olomouc, Czechia
Hospital Pardubice
Pardubice, Czechia
Charles University
Prague, Czechia
Masaryak's Hospital
Ústí nad Labem, Czechia
UMC St. Radboud West
Nijmegen, Netherlands
Eramus Medical Center
Rotterdam, Netherlands
Cheltenham General Hospital
Gloucestershire, United Kingdom
...and 4 more locations