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Topical rVA576 for treatment of atopic keratoconjunctivitis: a randomised placebo-controlled double masked parallel trial (TRACKER)
Full description
Recombinant rVA576 is a small protein (16.7kDa) which has two independent actions. It inhibits the activation and cleavage of complement C5 and it binds and inactivates leukotriene B4 (LTB4). It acts on the complement system by preventing the cleavage of C5 by C5 convertase into C5a and C5b and so is effective in inhibiting terminal complement activity irrespective of the activating pathway.
Atopic keratoconjunctivitis (AKC) is a type of allergic conjunctivitis which involves mast cell activation due to the predominance of inflammatory mediators such as eosinophils and Th2-generated cytokines (Mishra et al. 2011).
Recombinant rVA576 eye drops solution is the investigational medicinal product. It is intended for ophthalmic use by topical administration to the eye.
Recombinant rVA576 is a compact small protein molecule with a lipocalin-like structure consisting of alpha helices and a beta barrel. There is a surface-active site which binds to the complement C5 molecule with a high affinity (KD 1.85 x 10-8 M) and an internalised active site which binds the small eicosinoid molecule leukotriene B4 (Hepburn et al. 2007).
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Inclusion criteria
Exclusion criteria
Eye surface disease other than AKC
Contact lens use during the study
Complete or partial tarsorrhaphy. If such a procedure becomes necessary during the course of the trial patients may remain in the trial providing that at least 50% of the eye surface remains visible to slit lamp examination
Ankyloblepharon of any degree at entry to the trial
Known or suspected ocular malignancy
Active ocular infection at entry to the trial. Patients with eye surface bacterial, viral, fungal or protozoal infection may enter the trial after elimination of the infection as confirmed by eye swabs
Known or suspected uveitis
Participation in any other clinical trial within 1 month of enrolment
Use of any of the following prohibited medications:
Corneal perforation
Glaucoma
Pregnancy (females)
Breast feeding (females)
Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom)
Failure to satisfy the PI of suitability to participate for any other reason
Primary purpose
Allocation
Interventional model
Masking
12 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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