Cologne Ophthalmological Reading and Image Analysis Center CORIC
Establishing the first semiautomatic method of corneal blood and lymphatic vessel quantification in preclinical and clinical settings, Dr. Felix Bock built the base for the Cologne Ophthalmological Reading and Image Analysis Center (CORIC) in 2005. From 2006 on the team under the leadership of Prof. Dr. med. Cursiefen supervises Phase II and Phase III international, multi-center studies. In 2011 Prof. Cursiefen and Dr. Bock moved to Cologne and founded CORIC.
Our Ophthalmological Reading and Image Analysis Center offers solutions for preclinical and clinical studies regarding angiogenesis, lymph-angiogenesis and epithelial defects in the anterior part of the eye including cornea, conjunctiva and iris.
For clinical studies we provide on the one hand supervising of the attending centers including photographer training, image upload server, and quality control/management. On the other hand the centre analyses the images regarding the area covered by vessels, vessel length, vessel caliber and distance to the centre and limbus.
CORIC has a long lasting experience in performing Phase I, II and III multi-center studies about corneal neovascularisation and corneal surface defects. Further parameters like invasion front, maximum diameter of the lesion, corneal diameter etc. can be provided.
We use a semiautomatic method to quantify precisely the area covered by corneal blood vessels or epithelial defects stained with fluorescein. This method makes it possible to detect significant changes of neovascularisation in a range of 2% of the total corneal area.
For a safe data transfer we cooperate with the MIK Erlangen, which provide an eCRF platform. In close cooperation with their IT experts we develop individual eCRF solutions for each study to optimize the GCP conform transfer of the image data.
To ensure a standardized and high quality of the images all participating photographers has to pass an initial certification process to assess the image quality and sufficient photographing technique. This quality check is performed also during the study and CORIC is always in close contact with the centers/photographers via email or phone.
As a control tool for the sponsor/CRO we provide an image tracker which allows following up if images have been uploaded in time and if the quality of the images is sufficient for image analysis. Thereby the Sponsor/CRO can get in contact with the centers to clarify potential problems. [1-13]
- Corneal Neovascularisation: Semiautomatic image analysis: Area covered by vessels, vessel length, vessel caliber, maximal distance from limbus, minimal distance to center,
- Corneal epithelial defects: Area covered by epithelial defect, maximal diameter, perpendicular diameter, circumference, corneal diameter
- Assistance with clinical protocol development, including reading center-related outcome parameters and inclusion / exclusion criteria
- Development, provision and training of standardized photography protocols
- Instruction for clinical sites in methods for transmitting images captured for the study
- Image upload server administration
- Continues status update including image tracker and certification tracker
- Long-term archival of study materials, both digital and hardcopy
- Development of study-specific analyzing procedures and protocols
- I-CAN (Randomized, double-blind, multicenter, phase II clinical study, 10 centers in 3 European countries (Germany, Switzerland, and France)
- LX201-01 sub-study (Prospective, randomized, multicenter, controlled phase 2/3 clinical trial. The study comprised 43 trial sites in Germany, India, and the United States; EMA, FDA)
- STRONG (phase II/III, prospective, randomised, placebo-controlled, double-masked, three-armed multicentre study, EMA)
- NGF0212: Phase II multicenter, randomized, double-masked, vehicle-controlled trial, EMA)
- NGF0214: Phase II multicenter, randomized, double-masked, vehicle-controlled trial, FDA)
- Behaegel, J., et al., Short- and Long-Term Results of Xenogeneic-Free Cultivated Autologous and Allogeneic Limbal Epithelial Stem Cell Transplantations. Cornea, 2019. 38(12): p. 1543-1549.
- Bonini, S., et al., Phase II Randomized, Double-Masked, Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis. Ophthalmology, 2018. 125(9): p. 1332-1343.
- Lorenz, K., et al., A prospective, randomised, placebo-controlled, double-masked, three-armed, multicentre phase II/III trial for the Study of a Topical Treatment of Ischaemic Central Retinal Vein Occlusion to Prevent Neovascular Glaucoma - the STRONG study: study protocol for a randomised controlled trial. Trials, 2017. 18(1): p. 128.
- Engel, L.A., et al., Meibography and meibomian gland measurements in ocular graft-versus-host disease. Bone Marrow Transplant, 2015. 50(7): p. 961-7.
- Dogan, S., et al., Objectifying the conjunctival provocation test: photography-based rating and digital analysis. Int Arch Allergy Immunol, 2014. 163(1): p. 59-68.
- Cursiefen, C., et al., Aganirsen antisense oligonucleotide eye drops inhibit keratitis-induced corneal neovascularization and reduce need for transplantation: the I-CAN study. Ophthalmology, 2014. 121(9): p. 1683-92.
- Bock, F., et al., High-dose subconjunctival cyclosporine a implants do not affect corneal neovascularization after high-risk keratoplasty. Ophthalmology, 2014. 121(9): p. 1677-82.
- Bock, F., et al., Quantitative Analysis of Epithelial Defects and Neovascularisation after Cultured Autologous Oral Mucosal Epithelial Cell Sheet (CAOMECS) Transplantation for the Treatment of Corneal Limbal Epithelial Stem Cell Deficiency nvestigative Ophthalmology & Visual Science, 2014. 55.
- Koenig, Y., et al., Angioregressive pretreatment of mature corneal blood vessels before keratoplasty: fine-needle vessel coagulation combined with anti-VEGFs. Cornea, 2012. 31(8): p. 887-92.
- Koenig, Y., et al., Short- and long-term safety profile and efficacy of topical bevacizumab (Avastin) eye drops against corneal neovascularization. Graefes Arch Clin Exp Ophthalmol, 2009. 247(10): p. 1375-82.
- Cursiefen, C., et al., GS-101 antisense oligonucleotide eye drops inhibit corneal neovascularization: interim results of a randomized phase II trial. Ophthalmology, 2009. 116(9): p. 1630-7.
- Bock, F., et al., Improved semiautomatic method for morphometry of angiogenesis and lymphangiogenesis in corneal flatmounts. Exp Eye Res, 2008. 87(5): p. 462-70.
- Bock, F., et al., Bevacizumab (Avastin) eye drops inhibit corneal neovascularization. Graefes Arch Clin Exp Ophthalmol, 2008. 246(2): p. 281-4.