Subjects are being sought for trials to test the new Nova Oculus™ device as the only scientifically supported treatment for dry macular degeneration.
Presently, no scientifically proven treatment option is available for those with dry macular degeneration (dMD). Ongoing research, however, is showing that a new device using biocurrent technology (very low micro-current electrical stimulation) allows the retinal and macular cells to work more efficiently, improving vision and slowing the progression of macular degeneration.
People who have been diagnosed with dMD, who have vision no better than 20/40 and no worse than 20/200, and who are 50 years of age or older, may be eligible to participate in the research trial.
About the Study
The title of the study is BioCurrent Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration (Protocol Number WSW001). The principle investigator and sponsor is Wendy Strouse Watt, O.D. Treatment at this time will take place at DuBois Vision Clinic, 105 Beaver Drive, DuBois, PA.
The study has been approved by an Institutional Review Board (IRB) under the U.S. Department of Health & Human Services. It is a precursor to filing a 510K denovo application to the FDA. (“De novo” is a term for any method that makes predictions about biological features using only a computational model without extrinsic comparison to existing data.)
600 subjects will receive 24 treatments, 8 per day and the vision improvement is expected to last from 6 months to one year. The instruments are in-office only. None are sold to the participants, and there are no home units.
All subjects will receive actual therapy. After prior screening by phone and on-site, the expected treatment commitment of each qualified subject will be 3 days for on-site therapy and a follow-up exam on day 5. This includes an on-site screening visit, 3 days of on-site therapy, and a final visit on the last day of therapy.
Cost of Participation
Subjects will receive no payment for participating. Each will be responsible for his or her own costs, including experimental portions. Costs include normal charges for the eye care received during the course of the study. Costs of the examinations, photos, and testing will be billed to the subject’s insurance companies and third party payor. Insurance will not cover the investigational treatments. Those will be paid by each subject at $35 each ($840 total). Lodging and travel expenses during the trial will also be the responsibility of each subject. Discount rates at a local hotel are available to study participants. The study doctor is not being compensated to conduct the clinical trial.
About the Nova Oculus™ device
The Nova Oculus™ is an improvement upon the “off-label” micro current stimulation devices now in use. It is the first to be tested under FDA guidelines, and it is based upon a protocol that has been documented in scientific studies to safely and significantly improve vision in the majority of trial participants. It is also the first to have been designed specifically for ophthalmic use.
Research* over the past few years has shown that electrical stimulation around the eye yields positive trends in the majority of patients, specifically, an increase in visual acuity and contrast sensitivity. The therapeutic effect, though, seems to taper off over time. For that reason, the Nova Oculus™ protocol will require monthly treatment followups in the clinic. This is similar to the necessity for periodic drug re-treatments for the wet form of macular degeneration, with the payoff being the same: maintenance of vision and quality of life. Studies of biocurrent therapy have shown that the average length of time for keeping vision within 2 lines of baseline on the eye chart and being treated monthly, is 6.8 years. After treatment with the Nova Oculus™, patients have averaged 3-5 lines improvement in acuity.
For information about applying and to learn more about the study, contact Colleen Titman at 509-244-6502 or send email to [email protected] . The trial is also listed at clinicaltrials.gov.
*Supporting research:
Efficacy of Electrical Micro-Current Retinal Stimulation for Treatment of Dry Age-related Macular Degeneration (FDA Trial/Clinical Trial Registration No.NCT01600300).
Electrotherapeutic device/protocol design considerations for visual disease applications. O’Clock GD1, Jarding JB. (Conf Proc IEEE Eng Med Biol Soc. 2009;2009:2133-6. doi: 10.1109/IEMBS.2009.5333966.)
Transpalpebral electrotherapy for Dry Age-Related Macular Degeneration (MD): an exploratory trial. Anastassiou G1, Schneegans AL, Selbach M, Kremmer S. (Restorative Neurology and Neuroscience; 2013;31(5):571-8. doi: 10.3233/RNN-130322.
