Status:
TERMINATED
Topical rVA576 for Treatment of Atopic Keratoconjunctivitis
Lead Sponsor:
AKARI Therapeutics
Conditions:
Keratoconjunctivitis, Atopic
Keratoconjunctivitis, Vernal
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Topical rVA576 for treatment of atopic keratoconjunctivitis (AKC), vernal keratoconjunctivitis (VKC),and severe allergic conjunctivitis (seasonal (SAC) or perennial (PAC)): a randomised placebo-contro...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Aged 18 and above
- Diagnosis of moderate to severe AKC, VKC, or severe allergic conjunctivitis (seasonal or perennial). Defined as:
- AKC, VKC - a composite symptom/sign score from one eye of ≥ 18 out of 33
- Severe allergic conjunctivitis (SAC or PAC) - a composite symptom/sign score from one eye of ≥ 15 out of 27
- Will have had received some topical therapy during the last 3 months without improvement but will not currently be receiving systemic immunotherapy. Topical therapy may be topical calcineurin inhibitors, antihistamines or corticosteroids alone or in combination. Lubricants or artificial tears will not a count as topical therapy for these purposes.
- Will have had at least 7 days without topical ocular corticosteroids prior to entry
- Willing to give informed consent
- Willing to use highly effective contraceptive precautions for the duration of the study and for 90 days after the last dose of IMP
- Willing to avoid prohibited medications for duration of study (see list of prohibited medications)
Exclusion
- Eye surface disease other than AKC, VKC or severe allergic conjunctivitis (SAC or PAC)
- 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:
- Eculizumab
- Any other investigational complement inhibitor whether systemic or topical (e.g. RA101495)
- Montelukast
- Zafirlukast
- Pranlukast
- Zileuton
- Hypericum perforatum (St John's wort)
- Corneal perforation
- Uncontrolled glaucoma (increase in dose of glaucoma medication or surgical intervention for glaucoma within 3 months prior to entry)
- Pregnancy (females)
- Breast feeding (females)
- Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom)
- Use of topical ocular steroids within 7 days of the Screening visit
- Failure to satisfy the PI of suitability to participate for any other reason
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04037891
Start Date
March 4 2019
End Date
April 30 2020
Last Update
April 10 2025
Active Locations (9)
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1
Hospital Clinic de Barcelona
Barcelona, Spain
2
Instituto Universitario de Oftalmobiología Aplicada
Valladolid, Spain
3
Bristol Eye Hospital
Bristol, United Kingdom
4
Addenbrookes Hospital
Cambridge, United Kingdom