Neuro-Ophthalmology Research Disease Investigator Consortium
www.NORDICclinicaltrials.com
___________________________________
SPECIALIZED PROJECTS and
CLINICAL TRIALS in
NEURO-OPHTHALMOLOGY and
VISUAL NEUROSCIENCE
___________________________________
NORDIC Headquarters
1000 10th Ave.
10th Floor – INN
11th Floor – NORDIC Offices
New York, NY 10019
212-636-3516
July 2010
Introduction
Neuro-ophthalmology is a subspecialty of Neurology and Ophthalmology that is focused
on the scientific and medical issues of both specialties. Almost no prospective information
exists on many Neuro-ophthalmologic disorders; and with the lack of precise historical data
on the visual and systemic health, ophthalmologists, neurologists, internists and family
practitioners continue to perform many unnecessary, expensive, and potentially invasive
tests and to treat patients without evidence-based medical guidance. This can result in
initiating therapies that can be hazardous without a clear rationale.
Many neurological and systemic disorders affect the vision system, from the retina to the
occipital lobe and/or disrupt ocular motility causing many types of visual loss and
distortion, interfering with every aspect of daily living activities. Precise, reproducible,
standardized and accurate functional, structural and electrophysiological assessments mean
that these diseases and new therapies can be investigated in prospective studies and clinical
trials. NORDIC designs and manages these studies, providing agencies and sponsors a
network with the data needed to advance therapeutic interventions.
NORDIC was first conceived to address the many Neuro-ophthalmologic illnesses,
although uncommon, which have devastating effects on affected individuals. Individual or
small groups of Neuro-ophthalmologic investigators typically do not evaluate enough
subjects with most of these disorders to recruit an adequate number of subjects; to answer
the many unanswered questions about visual outcome, relation to systemic illness, and
effectiveness of current and future therapeutic interventions that require multi-site
observational and treatment trials. Establishing a consortium with a formal organization,
single data coordination and biostatistics center and a network of investigators will permit
the majority of Neuro-ophthalmologists to participate in multi-site observational and
treatment trials, facilitate the integration of new medical/scientific concepts, and ensure
recruitment of the necessary number of subjects for each study. Additionally, this
consortium and network will allow long range observational studies to be included (in order
to collect prospective data so that the more expensive and focused treatment trials will be
designed) or provide answers without a more expensive single purpose clinical trial.
2
July 2010
“NORDIC is about conducting research to solve the major issues that affect treatment of the eye
and neurological disturbances that disrupt vision.” …. M. Kupersmith, MD, NORDIC Chair
About NORDIC
The Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC) is a
specialized scientific research organization, created to facilitate the performance of multisite observational and treatment trials. The first aim of the consortium was and remains to
answer many important unanswered questions concerning risk, diagnosis, treatment and
management of Neuro-Ophthalmological conditions with focus on the research of scientific
and medical issues affecting vision, eye movements, pupil function, and visual quality of
life. NORDIC has expanded to perform planning, designing and conducting of clinical
trials to evaluate new therapies and vision system toxicity of agents, using precise functional
and structural assessment of the vision system.
NORDIC has developed clinical sites and committees essential for the start-up, conduct
and close-out of a clinical trial as well as to oversee the organizational component of the
consortium.





The Executive Committee (EC) coordinates all NORDIC activities with the
Data and Safety Monitoring Board (DSMB) and manages organizational
structure, including the network sites, the Data Coordination and Biostatistics
Center (DCBC), all committees, and reading centers.
The Scientific Review Committee (SRC) provides input on the feasibility and
science of a proposed clinical trial.
The Planning Steering Committee (PSC) and Study Steering Committee (SSC)
provide continued oversight of the study including experimental design, the
review process, enrollment, quality control, and statistical analyses.
Data and Safety Monitoring Board (DSMB)* is composed of a group of
individuals not directly involved in subject care or data collection in the trial.
The Quality Assurance Committee provides oversight to ensure quality control
throughout the lifecycle of a clinical trial and to ensure that every clinical trial is
conducted with the highest level of regulatory standards.
*The DSMB provides periodic review of accumulated data for evidence of adverse or
beneficial treatment effects, review the ethical conduct of a study, initiate recommendations
for modification of the study protocol, including termination of the treatment when
appropriate and assessing data quality and site performance.
“The NORDIC approach is a joint development leadership structure that spans POC/pilot studies,
translational, clinical and academic research.” …. Regional Project Coordintor
NORDIC has initiated a network of clinical trial sites throughout the US and Canada (with
planned expansion to Europe, Israel and Australia). A recent launch of 42 certified sites
within the network will increase the productivity and effectiveness of neuro-ophthmological
clinical research. NORDIC will continue to build a network of experienced Neuro3
July 2010
ophthamologists to conduct research and the investigators will be able to recruit within their
own patient population. Rather than select new sites and new investigators for every clinical
trial, the network of sites will be available for all NORDIC clinical trials.
NORDIC Expertise
NORDIC understands how vital specialized therapeutic knowledge and experience are to
delivering success in trials involving neurology and ophthalmology. All of NORDIC’s
certified Principal Investigators have demonstrated extensive experience, both in the clinic,
and in the practices of performing the highest level of trial research. Each member of our
team is capable of providing service to differing trial types, i.e. long-range observational,
biologic, pharmaceutical, diagnostic, and government-sponsored. Regardless of the design,
NORDIC’s highly-experienced team has a full understanding of their trials.
With specific expertise in vision system basic to clinical research, NORDIC has developed,
validated, and standardized outcome measures that can be used in clinical trials.
Standardized high contrast and low contrast acuity are tested using the same display
apparatus that is internally monitored. All sites have the same threshold perimeter and
softwared. Most sites have the same spectral high definition optic coherence tomography
and latest software. Fundus photography is standardized across all sites. NORDIC has the
only OCT Reading Center for spectral OCT studies. The Neuro-Ophthalmology Visual
Quality of Life Assessment tool is one measure NORDIC uses to correlate the
subject/patient perception with these measures.
The Certified Clinical Trial Site Advantage
The network of certified sites was created by NORDIC to provide organizational and
operational assistance to researchers in academia, industry, government and non-profit
institutions. NORDIC promotes the pursuit of innovative clinical research through the
connection of resources that historically stood as a barrier to the performance of such trials.
Investigators will be trained and certified for participation in treatment trials and
observational studies, and will be updated on procedures at least once a year.
Before a clinical trial site within the network can actively begin a clinical trial for NORDIC,
the site personnel must complete certification in visual acuity and refraction, visual fields,
fundus photography, optical coherence tomography, and lumbar puncture.
The purpose of the certification requirement is to assure that, to the extent possible in a
multi-center clinical trial, procedures are being performed in the same way and in
accordance with the study protocol in all network sites. The certification program is
supervised by the NORDIC Quality Assurance Committee and conducted by the
NORDIC Reading Centers.
4
July 2010
NORDIC Reading Centers
Visual Acuity/Refraction – University of Iowa
Visual Field – University of California, Davis
Fundus Photography – University of Rochester
Optical Coherence Tomography - University of California, Davis
The NORDIC Approach
NORDIC is an open investigator group, organized to provide a structured environment for
clinicians interested in studying Neuro-Ophthalmological disorders through participation in
clinical research studies. The consortium approach also provides the ability to incorporate
managed care settings as well as traditional private practice and medical center locales into
clinical trials. This provides researchers the ability to reach out to the maximum number
of potential participants, despite the challenges posed by the continuous change in the
delivery of health care.
Developed to provide strong central coordination of all participating sites, NORDIC’s
operational strategy has been designed to ensure that approved protocols can be easily
incorporated into standard clinical practice. All Network sites adhere to the guidance of
NORDIC management, headed by a governing Chair and Executive Committee (EC).
NORDIC’s operational functions are managed by leaders in the neuro-ophthalmic
therapeutic area and in the clinical research sector. With the added appointment of each
clinical study, a customized Study Steering Committee (SSC) is recruited, and data
collection/ management requirements are assessed by a Data Coordination and
Biostatistics Center (DCBC), staffed by persons qualified in managing data generated by
national and multi-site studies. Additionally, a Photographic Reading Centers (PRC) and
Visual Field Reading Center (VFRC) have been appointed to provide significant neuroophthalmic assessments when specified by the protocol.
“NORDIC addresses common as well as rare problems that affect the eye movements, optic nerve
and brain. We apply methodology to evaluate the latest translational research as well as established
therapies, for efficacy and toxicity” …. M. Kupersmith, MD, NORDIC Chair
5
July 2010
The Challenge of Quality Data
An ongoing challenge in managing the quality of clinical data is to continually monitor data
collection procedures at every level of the clinical trial. The efficiencies and cost-savings of
using one data coordination and biostatistics center (DCBC) and having one organizational
framework to foster, develop, and administer multiple studies are obvious. Conducting
clinical trials of such scientific significance using a dedicated organization will ensure that
standards of quality are being met.
“The NORDIC team provides a mutual exchange of time, resources and research
expertise.”…. NORDIC Headquarters Clinical Trialist
For each NORDIC clinical trial, the DCBC staff, in conjunction with the Study Steering
Committee (SSC), has the responsibility for overseeing the development of the protocol,
development of operational and analytical methodology, the conduct of each study
according to the protocol, and analysis of all data. The DCBC serves as an administrative
resource for study investigators. The center is actively involved in facilitating initial IRB
approvals, yearly renewals, amendment approvals and centrally tracking all of the final
approved documents.
Each site is trained to collect and enter quality data to the DCBC secure electronic capture.
Specific FTP sites are used to upload visual field, OCT, and fundus photography. This
allows immediate feedback and exceptional quality control from the NORDIC Reading
Centers.
Organizational and Operational Support
NORDIC offers services from comprehensive feasibility and project management to
clinical monitoring and patient recruitment services. Through efficient utilization of the
resources joined in networking an extensive group of Neuro-Ophthalmologists, NORDIC
is leading the way to conduct statistically-valid, cost-effective clinical trials in Neuroophthalmology. The NORDIC Team includes experts in pilot study creation, clinical trial
design, outcome measures, biostatistics, quality of life determinations, vision and nervous
system toxicity. Available services include:






Project Development and Planning
Protocol Development
Consulting Services
Case Report Form Design (EDC)
Administrative Services
Reporting Services






Site Monitoring
Safety Monitoring
Clinical Materials Services
Central Laboratory Services
Meeting Coordination
Biostatistics
Network of Clinical Trial Sites
6
July 2010
The following US-based and Canadian-based centers are the current NORDIC network of
clinical trial sites:
Canada
Hotel Dieu Hospital, Kingston, Ontario, Canada
The Montréal General Hospital, Montreal, Quebec, Canada
United States
Bascom Palmer Eye Institute, Miami, Fl
Bethesda Neurology, LLC, Bethesda, MD
Beaumont Eye Institute, Royal Oak, MI
Casey Eye Institute, Portland, OR
Dean A. McGee Eye Institute, Oklahoma City, OK
Department of Ophthalmology at UAB, Birmingham, AL
Department of Ophthalmology and Visual Sciences, Iowa City, IA
Doheny Eye Institute, Los Angeles, CA
Duke Eye Center, Durham, NC
Greater Baltimore Medical Center, Baltimore, MD
Jules Stein Eye Institute, Los Angeles, CA
LSU Surgical Facility, Baton Rouge, LA
Medical University of South Carolina, Charleston, SC
Massachusetts Eye and Ear Infirmary, Boston, MA
Michigan State University, East Lansing, MI
Mount Sinai Medical Center, New York, NY, NY
Neuro-ophthalmic Consultants Northwest, Seattle, WA
Neuro-Ophthalmology & Balance Disorders Clinic, Tallahassee, FL
Neuro-ophthalmology Department of Neurology, Peoria, IL
New Jersey Medical School, Newark, NJ
New York Eye and Ear Infirmary, NY, NY
OSU Eye Physicians and Surgeons, LCC, Columbus, OH
Raleigh Neurology Associates, Raleigh, NC
Saint Louis University Eye Institute, Saint Louis, MO
Stony Brook Ophthalmology, Stony Brook, NY
SUNY Upstate Medical University, Syracuse, NY
The Emory Clinic – Emory University, Atlanta, GA
The Eye Care Group, New Haven, CT
University Eye Institute, Houston, TX
University of Colorado, Aurora, CO
University of Michigan, W.K. Kellogg Eye Center, Ann Arbor, MI
University of Minnesota, Minneapolis, MN
University of Pennsylvania, Dept. of Ophthalmology, Philadelphia, PA
University of Rochester Eye Institute, Rochester, NY
University of St. Louis, St Louis, MO
University of Texas Science Center, San Antonio, TX
University of Utah, John A. Moran Eye Center, Salt Lake City, UT
University of Virginia, Charlottesville, VA
Wake Forest University Eye Center, Winston-Salem, NC
Wilmer Ophthamological Institute, Baltimore, MD
For More Information
7
July 2010
NORDIC has developed a web-site to ensure access to NORDIC resources, enhance
communication, and encourage information sharing. For a full description of NORDIC as
a scientific research organization, the web-site addresses NORDIC Policies, Mission
Statement and Current Research.
RFI can be obtained at info@NORDICclinicaltrials.com
New study ideas or a RFP can be submitted at NORDIC@NORDICclinicaltrials.com
8