Patient enrolment in the Phase III clinical study (ODAK 043/SI) aimed at developing a safe and effective drug for the treatment of Acanthamoeba keratitis.
The phase III clinical trial of the ODAK Project (Orphan Drug for Acanthamoeba Keratitis) (ODAK 043/SI) outperforms after one year (https://www.oculistaitaliano.it/articoli/progetto-odak-parte-italia-lo-studio-clinico-fase-iii/) the important milestone of 50% (65 out of 130) enrolled patients.
The centres
The centres involved in recruitment are:
- Moorfields Eye Hospital in London (Prof. John Dart);
- Manchester Royal Eye Hospital (Dr. Fiona Carley);
- the University Hospital Southampton (Dr. Parwez Hossain);
- the San Raffaele Hospital in Milan (Dr. Paolo Rama);
- the SS Giovanni e Paolo Hospital in Venice (Dr. Antonella Franch)
- the University Clinical Center Medical University of Silesia in Katowice (Dr. Ewa Mrkwa Kominek)
Pathology
La Acanthamoeba keratitis (CA) is a rare disease ('orphan disease'), affecting less than 0.1 in 10,000 EU citizens.
Acanthamoeba is a microbial protozoan with a life cycle consisting of two main phases: trophozoite and cyst. While the former is sensitive to the most common chemotherapeutic agents, the latter is an inactive form that can survive in extreme environmental conditions.
Patients with CA generally experience severe eye pain, photophobia, eye redness and irritation, blurred vision and excessive tearing.
Clinical signs include annular stromal infiltrates, epithelial defects and eyelid oedema.
Contact lens wearers are particularly at risk and account for up to 85 % of CA cases.
Patients often present with very severe forms of Acanthamoeba infection and about 25% of them have to resort to corneal transplantation.
The project
ODAK is a project activated under the 'Seventh Framework Programme' under the auspices of the European Commission and today sponsored and coordinated exclusively by SIFI SpA (Italy). The aim of the ODAK project is to develop PHMB 0.08% eye drops in the effective and safe treatment of Acanthamoeba keratitis.
For further information: :
Antonino Asero, ODAK project director
Antonino.Asero@sifigroup.com
Read also the interview:
Acanthamoeba keratitis and medical therapy
Dr. Carmelo Chines
Direttore responsabile
English 
Italian