The clinical research team at Cincinnati Eye Institute (CEI) is lighting the way in innovative ophthalmology exploration.
CEI not only provides incredible patient care but is a leader in ophthalmology clinical trials and research in all areas of ophthalmology. It’s all part of CEI’s commitment to bringing the most advanced eye care treatments and vision solutions to Cincinnati and Northern Kentucky.
Retina Studies
“Our CEI retina research team oversees one of the most cutting-edge research programs in the United States,” explains Daniel Miller, M.D., Ph.D., CEI’s Chief Medical Officer. “At any time, the CEI retina team is conducting five to six new clinical trials with novel therapies for common blinding diseases such as macular degeneration, diabetic retinopathy, and retina vein occlusions.”
In addition to Dr. Miller, CEI’s retina research team includes Luke Lindsell, O.D., M.D.; Robert Foster, M.D.; James Osher, M.D.; Robert Sisk, M.D.; and Christopher Riemann, M.D.
The retina plays a vital role in your vision. It is a thin tissue that lines the inner surface of the back of the eye. When the light-sensitive cells inside the retina receive information, they send it to the brain through the optic nerve, enabling you to see. Dr. Osher, an eight-year retina specialist, commends his colleagues and the clinical trial team for their dedication to and continued passion for blazing trails in ophthalmology, and their steadfast commitment to their patients.
“Clinical trials are one of the amazing services we offer. It’s patients benefitting patients,” he says.
According to Dr. Osher, gene therapy is a “blossoming area” in medicine. “Currently, retina and oncology are the only two fields laying the groundwork for research in this area. This has allowed doctors to make significant strides in macular degeneration,” he notes.
Macular degeneration is an eye disease that causes loss in the center of the field of vision. In dry macular degeneration, the center of the retina deteriorates. With wet macular degeneration, leaky blood vessels grow under the retina. Macular degeneration is the leading cause of blindness in adults 65 and older. Using gene therapy, doctors reprogram tissues and genetic makeup so patients begin to produce healthy cells.
“Patients can see the world in a new way,” Dr. Osher says.
“We are making an impact with the improvement of drugs, medicine, and therapies. These trials are curing blindness.”
Leading the retina research management team is Director of Clinical Research for Eyecare Partners Megan Kingdon, R.N., COA, CCRC. The retina research team consists of three coordinators, two vision technicians, and three photographers. “We are often running 30 trials at any given time,” she says.
Kingdon began her ophthalmic career as a technician at CEI 20 years ago, earned her nursing degree, and moved to the clinical trial program. “I have always had a mind for research, and I love being part of a field that can bring the next best treatment to our patients.”
FDA Approvals
Two CEI clinical trials received Food and Drug Administration (FDA) approval in recent months. In October 2021, the FDA approved Genentech’s Susvimo, a first-of-its-kind therapeutic approach for wet age-related macular degeneration (AMD). Susvimo, previously called Port Delivery System with Ranibizumab, is the first alternative to standard eye injections that typically are needed as often as once a month. This treatment offers as few as two treatments per year. Susvimo delivers ranibizumab continuously. The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months. This treatment option dramatically and positively effects the more than 1 million people in the United States who suffer from wet AMD.
“Susvimo has been one of the most exciting and cutting-edge technologies that we have developed from research trial to FDA approval,” says Dr. Miller, who performed the second Susvimo implant in the United States about five years ago.
Additionally, CEI was a leading research center investigating the benefits of Vabysmo, a prescription medicine designed to target and inhibit two disease pathways linked to a number of vision-threatening retinal conditions. It was approved by the FDA in January. The first antibody for the eye that treats two leading causes of vision loss, Vabysmo is the only injectable eye medicine approved in the U.S. for wet AMD and diabetic macular edema (DME). It allows flexible dosing based on patient need and lessens the burden of monthly injections.
On the Horizon
Another clinical trial beginning soon is the use of the drug methotrexate in the prevention and treatment of proliferative vitro-retinopathy (PVR) or retinal detachment. Researchers have discovered that methotrexate, a drug used for auto-immune diseases, can blunt the growth of scar tissue. In post-retina reattaching surgery, scar tissue can develop over time causing the retina to detach. This could be an incredible advancement in the long-term success of retina reattachment surgery.
“In 10 years of clinical trials, we have helped over 300 patients through injection, device trials and gene therapy. It is exciting to see this dramatic change. We are meeting the unmet need.”
Anterior Segment/Glaucoma
Regional Clinical Research Manager of Ohio, Kelye Conrad, COT, CCRC, has been in the field of ophthalmology for 20 years, and involved in several trials and advancements during her six years at CEI. Working with Michael E. Snyder, M.D., Anterior Segment Research Investigator, they received FDA approval in 2018 for an iris prothesis — the CustomFlex Artificial Iris (HumanOptics). It’s designed for the treatment of vision and cosmetic problems arising from congenital, surgical, or traumatic aniridia (lack of an iris) in adults and children. The iris is much like a window shade for the eye. Without an iris, it can be difficult to perform normal daily activities, not to mention the cosmetic appearance of an eye without one.
“Patients came from all over the country for the trial," Conrad recalls.
The iris prosthesis is a silicone implant that is placed inside of the eye, much like an intraocular lens after cataract surgery. These implants are special-ordered, hand-painted in Germany, and specific to each patient. Dr. Snyder specializes in this reconstruction surgery and performs several each month.
Currently, anterior segment and glaucoma specialists are conducting drug and device studies for not only glaucoma but ocular hypertension, post-operative inflammation and pain after cataract surgery, and various corneal dystrophies.
Cincinnati is blessed to be the home of an incredible health care network. Cincinnati Eye Institute plays a key role in this network and continues to provide innovative research in the development of treatments to make sight possible for all.
“Research is how we move forward,” Conrad explains. “Because of it, we are able to offer our patients the latest and greatest in eye care.”
Are you struggling with your vision or experiencing other problems with your eyes? Cincinnati Eye Institute can help. To make an appointment, visit cincinnatieye.com.