Conditions: Glaucoma
Keywords: glaucoma, trabeculectomy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 124
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) arm 2: Placebo

Interventions: intervention 1: PRM-151 intervention 2: Placebo
Intervention descriptions: intervention 1: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9 intervention 2: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Protocol document: