Journal of Neuro-Ophthalmology, March 2011, Volume 31, Issue 1

Research in Neuro-Ophthalmology- Update on NORDIC and the IIHTT

Research in Neuro-Ophthalmology: Update on NORDIC and the IIHTT On February 6, 2009, the Neuro-Ophthalmology Research Disease Investigator Consortium (NOR-DIC) was officially established. Its mission, organizational structure, requirements, and announcement of the first clinical trial were detailed in the Journal ofNeuro-Ophthalmology (1). Significantly, NORDIC is funded for 5 years through a National Eye Institute (NEI) U10 mechanism. Although NORDIC was originally developed through the efforts of the members of the North American Neuro-Ophthalmology Society (NANOS), NORDIC is independent of NANOS and NORDIC investigators are not required to be members of NANOS. For further information about NORDIC and the requirements of investigators, please consult the NORDIC Web site: www.nordicclinicaltrials.com. The purpose of this report is to detail the progress of the first prospective, placebo-controlled, randomized clinical trial under the NORDIC umbrella: the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT). What is the IIHTT? The IIHTT was developed by the study director, Michael Wall, MD, and the IIHTT steering committee, along with the chair of the NORDIC executive committee, Mark Kupersmith, MD. The purpose of the IIHTT is 1) to determine if acetazolamide provides additional benefit to a low-sodium weight-reduction diet in reducing visual loss in patients with IIH associated with a mildly decreased mean deviation on automated perimetry. Secondary end-points for the study include papilledema grade, multiple visual field parameters, and quality-of-life measures, and 2) to identify proteomic and genetic risk factors for IIH patients and controls. In particular, an attempt will be made to determine the pathogenesis of IIH, particularly as it relates to obesity or at least being overweight. A data coordination and biostatistics center (DCBC) functions as a resource for study investigators and as a central repository for database control and management. Centralized reading centers have been set up to evaluate tests of visual function as well as OCT and fundus photographic images. Patients will be followed for 4 years. What is the current status of the IIHTT? At the present time, 43 centers are participants in the IIHTT and currently are prepared to enroll patients (Fig. 1). FIG. 1. IIHTT trial sites. Section Editor: Kathleen B. Digre, MD 98 Gordon and Miller: J Neuro-Ophthalmol 2011; 31: 98-99 Neuro-Ophthalmology News Copyright © North American Neuro-Ophthalmology Society. Unauthorized reproduction of this article is prohibited. The study plans to enroll a total of 152 subjects and con-trols. Participating sites can be found on the following Web site: http://www.nordicclinicaltrials.com/Pages/ CurrentResearchIIHTT.aspx. These sites received approval to conduct the study under their local institutional review board and have received certification for individuals par-ticipating in data collection (ophthalmic technicians, visual field technicians, and photographers). As of November 1, 2010, 16 subjects and 1 control had been enrolled in this study. What are the enrollment criteria for potential subjects? To be included in the IIHTT, potential subjects must be referred to a participating center in a timely way in order to determine eligibility. The following summarizes the in-clusion criteria: 1. Meets the modified Dandy criteria for IIH 2. Perimetric mean deviation of 22 to 25 dB 3. Diagnosis of IIH was made within 6 weeks of study entry 4. Subject has received treatment for IIH for less than 1 week 5. Subject has bilateral optic disc edema 6. Patient must be willing to comply with the study protocol and be randomized to either acetazolamide or placebo in addition to the dietary changes. It is preferable to refer a potential subject for evaluation prior to the lumbar puncture in order to be able to obtain CSF for additional testing. Why might patients be willing to enter the study? In addition to the typical reasons that patients may enter clinical trials, all enrolled subjects will receive access to individual counseling and a formalized weight loss regimen through the New York Obesity Research Organization. This organization has a waiting list for patients and is highly regarded. The majority of individuals who have IIH are obese or at least overweight and may obtain benefit from participating in this program, which includes dietary changes and monitoring, physical activity as measured with a pedometer, and behavioral changes. Counseling is pro-vided through a weekly telephone appointment. If I am not a NORDIC site, how can I refer patients for the IIHTT trial? Information can be found at the IIHTT Web site http:// www.nordicclinicaltrials.com/Pages/CurrentResearchIIHTT. aspx or you can contact either the individual site orNORDIC headquarters by telephone: [phone] or by e-mail: [e-mail]. Are there NORDIC studies or trials other than the IIHTT? NORDIC seeks to initiate other prospective clinical trials and is in the process of reviewing potential new studies; however, at the present time, the IIHTT is the only study or trial being performed by NORDIC members. How are new studies developed? NORDIC is always interested in new proposals for the consideration of future clinical studies and trials. Each study ideally should be hypothesis driven, have clinical and sci-entific underpinnings, tackle an important health issue, and have measurable outcome measures. Anyone who has an idea for new research should access the project proposal template on the Web site at: http:// www.nordicclinicaltrials.com/Pages/default.aspx. The pro-posal should include the objectives of and rationale for the project as well as a brief synopsis. Once a project proposal is submitted, the NORDIC New Project Proposal Review Committee (NPPRC) will evaluate the proposal and make a recommendation for approval or disapproval to the NORDIC Executive Committee. If the study is approved by the NORDIC Executive Committee, the project will be developed in conjunction with NORDIC. Further details and requirements were previously published (1). Lynn K. Gordon, MD, PhD Neil R. Miller, MD on behalf of NORDIC (Neuro-Ophthalmology Research Disease Investigator Consortium) REFERENCE 1. Kupersmith MJ, Miller N, Balcer L, Gordon L, Wall M, Keltner J, Friedman D, Feldon S, McDermott M, Kieburtz K. The Neuro- Ophthalmology Research Disease Investigator Consortium (NORDIC). J Neuroophthalmol. 2009;29:259-261. Gordon and Miller: J Neuro-Ophthalmol 2011; 31: 98-99 99 Neuro-Ophthalmology News Copyright © North American Neuro-Ophthalmology Society. Unauthorized reproduction of this article is prohibited. [CLiihtt]