Research focused on reversing and preventing blindness


Today’s medical environment offers a myriad of research opportunities for ophthalmology educators and practitioners. Through our research efforts, faculty at the Havener Eye Institute are helping to reverse and prevent blindness for patients.

We are always recruiting patient participants for our clinical trials.

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Clinical Trials

Clinical Trials

The Department of Ophthalmology and Visual Science provides opportunities to join research studies listed below. For more information on studies related to retinal detachment, glaucoma, intracranial idiopathic hypertension and presbyopia research, please contact the research office at 614-293-5287 or research@osumc.edu.

Opthea Clinical Trial Macular Degeneration Research Study

AMD is the leading cause of blindness in people over 50 years of age. It is caused by the breakdown of the central portion of the retina (the nerve layer part of your eye that works like the film in a camera to pick up the picture) called the macula. The macula is responsible for the fine central vision in the eye that is needed for driving a car, reading fine print, recognizing faces, etc.

There are two types of macular degeneration: dry (non-neovascular) and wet (neovascular). In the "wet" form of AMD, abnormal blood vessels grow in the back of the eye. Sometimes these vessels leak blood or fluid that causes blurred and distorted vision. This process is also known as choroidal neovascularizaion (CNV). For people affected by "wet" AMD, vision loss may be quick and severe. This study is for participants with "wet" AMD. The purpose of this study is to evaluate the effects of investigational drug in research participants with wet AMD, and how it is absorbed into the body, when administered in combination with other AMD drugs. An investigational drug is one which has not been approved by the U.S. Food and Drug Administration (FDA) but is available in research studies like this one.

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Bimatoprost Clinical Trial Glaucoma Research Study

Glaucoma is a family of diseases commonly characterized by progressive optic neuropathy with associated visual field defects and is the leading cause of irreversible blindness in the world. Glaucoma is classified into 3 types: developmental, angle-closure, and open-angle glaucoma (OAG).

Open-angle glaucoma is further categorized into primary OAG (POAG) and secondary OAG.  It is estimated that 2.25 million people in the United States over the age of 40 years have POAG, half of whom are unaware of their disease.

The efficacy of LUMIGAN (bimatoprost ophthalmic solution) 0.03% is well established. A sustained-release implant of Bimatoprost was developed as an alternative to eye drops. This study will evaluate the eye pressure lowering efficacy and safety of Bimatoprost sustained-release compared to topical eye drops in patients with OAG.

Boulevard Clinical Trial Diabetes Research Study

The purpose of this research study is to investigate the effects and safety of RO6867461 administered intravitreally in patients with diabetic macular edema (DME).

Diabetic macular edema (DME) is the term used for swelling in the small central part of the retina used for sharp straight ahead vision due to diabetes. The retina is a thin layer of tissue that lines the back of your eye. It is nourished by blood vessels that become affected by diabetes.

Anti-VEGF drugs are injected into the eye to block a substance called vascular endothelial growth factor. These drugs have been used to treat DME because abnormal levels of VEGF are produced by retinas affected by diabetes. These abnormal levels of VEGF can cause leakage of fluid from retinal blood vessels, which can cause swelling of the retina and potentially vision loss. There are several anti-VEGF drugs. All participants will receive either Lucentis® or the experimental drug, RO6867461. No one will receive a placebo.

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Panorama Clinical Trial Diabetes Research Study

Nonproliferative diabetic retinopathy (NPDR) is a leading cause of vision loss in patients with diabetes. NPDR occurs when the blood vessels within the retina (a tissue at the back of the eye) start to leak or bleed causing vision to be blurred and distorted. The retina is located at the back of the eye and controls central vision.

There are two types of diabetic retinopathy, nonproliferative and proliferative, each with varying stages of severity. In the earliest stages, the damaged blood vessels within the retina begin to leak. This leakage causes the retina to swell and vision to distort. Patients with type one or type two diabetes can develop NPDR. The chance of getting NPDR is higher if you have had diabetes for a long time or your blood sugar (glucose) has been uncontrolled.

The purpose of this study is to evaluate the effects of an investigational drug in research participants with diabetic retinopathy. An investigational drug is one which has not been approved by the U.S. Food and Drug Administration (FDA) for a particular use but is available in research studies like this one.

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Sequoia Clinical Trial Macular Degeneration Study

AMD is the leading cause of blindness in people over 50 years of age. It is caused by the breakdown of the central portion of the retina (the nerve layer part of your eye that works like the film in a camera to pick up the picture) called the macula. the macula is responsible for the fine central vision in the eye that is needed for driving a car, reading fine print, recognizing faces, etc.

There are two types of macular degeneration: dry (non-neovascular) and wet (neovascular). In the "wet" form of AMD, abnormal blood vessels grow in the back of the eye. Sometimes these vessels leak blood or fluid that causes blurred and distorted vision. This process is also known as choroidal neovascularizaion (CNV). For people affected by "wet" AMD, vision loss may be quick and severe. This study is for participants with "wet" AMD. The purpose of this study is to evaluate the effects of investigational drug in research participants with wet AMD, and how it is absorbed into the body, when administered in combination with other AMD drugs. An investigational drug is one which has not been approved by the U.S. Food and Drug Administration (FDA) but is available in research studies like this one.

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Omaspect Extension Clinical Trial Macular Degeneration Study

We are conducting a clinical trial to evaluate a drug called lampalizumab for patients with geographic atrophy (GA), a form of dry age-related macular degeneration (AMD).

GA causes progressive damage to the macula, the central region of the retina (inside the eye), which is involved in seeing the fine details associated with reading, driving and recognizing faces. In the advanced stage of the disease, GA results in severe central vision loss, which impairs performance of many activities of daily living.

The cause of AMD is not well understood. However, recent scientific studies have found that people with specific inherited (genetic) characteristics have an increased risk of AMD. Other scientific studies also suggest that an increased activation of a specific part of your immune system called the "alternative completment pathway" may be involved in the disease. Currently, there is no approved treatment for GA. Lampalizumab, the study drug, is designed to slow down the activation of the alternative complement pathway and is given by injection into the eye.

The purpose of this study is to compare the effects, good or bad, of lampalizumab versus sham (false) injection and also to see if lampalizumab works differently in people with specific inherited (genetic) characteristics with an increased risk of AMD. In this study, participants will get either lampalizumab or sham injection.
Innovative and Translational Research

Innovative and Translational Research

Polymorphisms is Retinal Detachment with Proliferative Vitreoretinopathy

Proliferative vitreoretinopathy (PVR) is a connective tissue condition that has been known to cause legal blindness after a retinal detachment. In other severe connective tissue diseases, such as scleroderma and rheumatoid arthritis, it has been discovered that the Macrophage migration inhibitory factor (MIF) carries multiple genetic variations. Macrophage MIF is a protein involved in promoting inflammation and cell proliferation by inhibiting our cells’ ability to program its own death. Currently, there are no successful pharmacologic inhibitors of PVR causing it to be a persisting complication from retinal detachments despite multiple surgical attempts aimed to remove it. 

In this study, we aim to test:
  • if Macrophage MIF is up-regulated in PVR subjects
  • if disease-associated polymorphisms of MIF are more prevalent in subjects with PVR than without PVR
  • if other candidates determined from iTRAQ proteomic animal model studies are up-regulated in PVR
In order to meet our goals for this study subjects will be asked for a blood draw or cheek cell sample and a tissue sample obtained during surgery by your surgeon. Collected samples are then sent to our lab for further testing which includes, but not limited to, ELISA testing, Western blot, iTRAQ proteomic analysis, and PCR. 

Potentially, this study can lead to:
  • the identification of risk factors for PVR for which patients with retinal detachment could receive screening
  • the discovery of a potential biomarker for PVR
  • the discovery of key pathogenic proteins for PVR progression that could be targeted with drugs to block PVR

Prostaglandins on the Biomechanical Properties of the Cornea

We are excited to introduce a clinical research study being conducted at the Havener Eye Institute at The Ohio State University for both new and established glaucoma patients. The study is funded by the Columbus Foundation, Anne Ellis Fund. The measurements taken for this study are for research purposes only.  This is not a referral or treatment for a condition.

Title: The Effect of Prostaglandins on the Biomechanical Properties of the Cornea 
PI: Shelly Jain, MD and Cynthia Roberts, PhD.
Goal: Determine if topical prostaglandin analog use softens the cornea, causing an underestimation of intraocular pressure via applanation tonometry.

  • Patients receiving prostaglandins for first time
  • Treating  physician will continue management of patients glaucoma
  • Research visits conducted at OSU; scheduled through research office
  • All study visits will be scheduled around your clinic schedule
  • Research visits conducted within 1-2 days of clinical visit; first visit must occur prior to starting prostaglandin
  • Three study visits:  baseline,1 month and 4 months; visits will last between 30-45 minutes
  • Visit includes 6 eye measurements and blood pressure
  • Treating physicians provide copies of medical records including cup to disc and visual field
  • Subjects will receive $100 at completion of three visits 
  • Physicians who recruit patients will be acknowledged on any study related publications

New Mechanism for Optic Nerve Damage in Glaucoma

We are excited to introduce a clinical research study being conducted at the Havener Eye Institute at The Ohio State University for both new and established glaucoma patients. The study is funded by the Columbus Foundation, Anne Ellis Fund. The measurements taken for this study are for research purposes only. This is not a referral or treatment for a condition.

Title: Investigation of a New Mechanism for Optic Nerve Damage in Glaucoma       
PI: Gloria Fleming, MD and Cynthia Roberts, PhD
Goal: Investigating the influence of the pulsatile component for both ICP and IOP on damage to the lamina cribrosa 

  • Patients who have OHT, NTG, POAG   
  • Single study visit, lasting approximately 3-4 hours; scheduled on Saturdays 
  • Separate 30 minute appointment for consent and paperwork
  • Research visits conducted at OSU   
  • Visit includes 8 eye measurements, blood pressure and ultrasound guided LP
  • Subjects will receive $250 if study visit is completed 
  • Primary physicians provide copies of medical records if necessary

Ocular Elastography

Jun Liu, PhD, associate professor, Department of Biomedical Engineering (BME), recently received notification that her R01 grant submission has been accepted by the National Institute of Health (NIH), awarded in the amount of $1.8 million, and will be funded for five years.  The title of her research is “Ocular Pulse Elastography” and her Co-Investigators include Thomas Mauger (Ophthalmology), Cynthia Roberts (Ophthalmology and BME), Paul Weber (Ophthalmology) and Jeff Pan (Center for Biostatistics, at Ohio State).

The proposed research will test and establish an innovative technique for quantitative evaluation of the cornea's biomechanical responses and properties in vivo, which will offer a new clinical tool to acquire the functional properties of the cornea. Current approaches for corneal biomechanical characterization often rely on an external force to deform the cornea in order to induce a mechanical response. In addition, most methods do not explicitly address the influence of the intraocular pressure (IOP) on the measured properties. In this project, we aim to build and optimize an ultrasound elastographic technique to characterize the cornea’s response to the cyclic variation of IOP at each cardiac cycle, i.e., the ocular pulse. The baseline IOP and ocular pulse amplitude, which are all measurable in vivo, will be used in combination with the biomechanical measures to derive the intrinsic tissue biomechanical properties that are independent of the IOP parameters. Our preliminary studies have demonstrated that the ocular pulse elastography (OPE) technique, based on high frequency ultrasound radiofrequency data analysis, can provide a strain resolution of 0.05% and better, making it possible to reliably track small in vivo strains induced by an ocular pulse of a few mmHg. The proposed research will establish clinically viable technique to help diagnose debilitating eye diseases such as corneal ectasia at an early stage, and provide a non-invasive, safe tool to guide therapy and monitor treatment response. 

Dr. Liu has filed for a patent for the proposed technique and two groups of BME undergraduate students are involved in building some aspects of the measurement apparatus for their senior capstone design project.

Adaptive Optics Imaging

Adaptive optics researchers Stacey Choi and Nathan Doble from The Ohio State University College of Optometry work with us on a collaboration to enable us to visualize individual neurons in the retina. We are one of six such centers in the country with this technology. The goal of this work is to develop a powerful clinical tool to detect early, objective microstructural changes in the retina and biomarkers of disease. This technology will be critical to developing the objective measures needed to evaluate clinical trials of novel retinal therapeutics. Faculty from the Department of Ophthalmology who are involved in this study include Drs. Ohr, Davidorf, Abdel-Rahman and Cebulla.

Traumatic optic neuropathy and traumatic brain injury are common after battlefield trauma and other traumatic injuries. Our new collaboration with biomedical engineer Matthew Riley, adaptive optics researchers Nathan Doble and Stacey Choi, Abdel-Rahman (ocular path) and Cebulla (ophthalmology) is working towards identification of mechanisms of neuronal loss and neuroprotection.

Imaging of individual retinal ganglion cells in living human eyes

Nathan Doble, PhD, along with Stacey Choi, PhD and Mark Slabaugh, MD from the Department of Ophthalmology were awarded $100,000 over two years from the Ann Ellis Fund. The grant will use the AO-optical coherence tomography (OCT)-scanning laser ophthalmoscope (SLO) system to image individual retinal ganglion cells (RGCs) and nerve fiber bundles (NFBs) in healthy and glaucomatous eyes and correlate these findings to functional measures such as visual fields. The work will allow for a much earlier diagnosis of glaucoma than standard clinical tests and a better understanding of the pathophysiology of the disease.

AMD Sustained Release

Dr. Katelyn Swindle-Reilly and Dr. Matthew Ohr are researching a proposal titled “Sustained Release Bevacizumab Injectable for the Treatment of Wet Age-Related Macular Degeneration”
Dr. Ohr and Dr. Reilly have developed a unique technology to tailor drug release from biodegradable polymer microparticles. Use of this technology will allow for sustained release of Bevacizumab (anti-VEGF) into the vitreous and hence reduce the frequency of drug administration.
 
Read more about the funding of this project by the Lois Hagelberger-Huebner Young Investigator Award.

Ocular Melanoma Genetics and the BAP1 Tumor Predisposition Syndrome (BIG Consortium)

Ocular melanoma is a form of melanoma in which cancer cells from the inner pigmented layer (known as the uvea) form inside the eye. The tumor is also called ocular or intraocular melanoma. This tumor is different from tumor arising from the ocular surface called the conjunctiva (conjunctival melanoma). Ocular melanoma can be fatal and researchers at OSU are devoted to ending deaths from this cancer.

Ocular melanoma research at Ohio State

The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute (OSUCCC – James) has a strong ocular melanoma genetics discovery program.

*Discovery of the BAP1 Tumor Predisposition Syndrome (OMIM 603089)(OSU faculty: Abdel-Rahman, Pilarski, Cebulla, Davidorf)
This autosomal dominant syndrome caused by germline mutation of BAP1 was simultaneously discovered by our group at OSU and two other groups. It causes uveal (ocular) melanoma, which is the most frequent and youngest presenting cancer (age 16). Other tumors include cutaneous melanoma, mesothelioma, renal cell carcinoma, atypical Spitz nevi, basal cell carcinoma, and others.

Interest in the new BAP1 syndrome has led to formation of the BIG Consortium – an international group of scientists and clinicians dedicated to learning and improving outcomes for patients with the BAP1 syndrome. Our group has developed screening guidelines for patients with the syndrome. Our group is starting a registry for these patients and offers care for patients with the BAP1 syndrome.

*The OSUCCC – James is one of six centers worldwide for the NIH Cancer Genome Atlas (TCGA) project for uveal melanoma. Dr. Cebulla led Ohio State’s participation as a tissue source site, and our group served on the clinical working group and writing group for the major uveal melanoma marker paper. Participating faculty include Drs. Cebulla, Abdel-Rahman, Pilarski, and Schoenfield.

*Ohio State is part of a multicenter adjuvant clinical trial for high-risk uveal melanoma (grants.gov NCT02223819, OSU 14129). Thomas Olencki, DO, is the local principal investigator for this trial, titled "Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy." The trial opened at Ohio State in September 2016. Preclinical data supporting this class of medication for uveal melanoma comes from Abdel-Rahman's work. (PMID: 20164465)

OSUCCC-James is a leader in the nation for offering clinical trials to patients with advanced uveal melanoma.

Other studies and information

*Active Uveal Melanoma Genetics Discovery Program
Our multidisciplinary group (Davidorf, Abdel-Rahman, Cebulla, Pilarski) has developed the largest cohort of familial uveal melanoma patients in the world. There are 117 families reported in the literature, and we have 32 families in our cohort. Our work identified an increased incidence of BAP1 mutation in familial uveal melanoma (22 percent compared with one to two percent in unselected uveal melanoma).This cohort is powerful for discovery of the genes that predispose to uveal melanoma and other cancers. (PMID: 27718540)

*NIH funding R21CA1919R43 Abdel-Rahman (PI) on “Hereditary Predisposition Syndromes in Uveal Melanoma.”

*Our group helped identify that variations in HERC2-- and other genes that control eye color—are risk alleles for uveal melanoma. The discovery has been recognized in the media. It is significant that the pigmentation differences may yield a direct risk for cancer, beyond their UV-blocking functions. (PMID: 27499155)
 
*Our group identified genetic and pathologic factors associated with long vs. short survival with uveal melanoma metasisis, or spread. (PMID: 22569040) 

Corneal Biomechanics in Ocular Disease

New research led by Dr. Cynthia Roberts (Professor of Ophthalmology & Visual Science and Biomedical Engineering) along with a team of ophthalmologists and engineers could lead to more accurate screening and monitoring of glaucoma and other eye diseases. The study has received a $1.925 million R01 grant from the National Institutes of Health (NIH) to examine the separate effects of corneal stiffness and intraocular pressure (IOP) on the biomechanical assessment of the eye. IOP, or the pressure inside the eye, is an important factor when assessing risk for eye disease, particularly glaucoma, explained Dr. Roberts. Current measurement techniques – such as the common puff-of-air test which causes the cornea to deform – can render inaccurate pressure readings if a cornea is abnormally stiff or soft. “The higher the IOP, the stiffer the behavior,” said Roberts. “That’s a problem, because how do you know when this deformation is measured, if it’s due to stiffness or IOP? You can’t tell, so one of the most important goals of this grant is to separate stiffness from IOP in these clinical deformation parameters.”

Roberts said the team will also explore ways to measure corneal stiffness specifically. Roberts’ co-investigators include Jun Liu, PhD (Professor of Biomedical Engineering and Ophthalmology), Paul Weber, MD (Professor Emeritus of Ophthalmology) and Matthew Ohr, MD (Associate Professor of Ophthalmology). The study will involve two phases. Using a novel stiffness parameter, Roberts and her colleagues will compare deformation responses of paired donor eyes in a controlled lab setting where stiffness can be altered and measured. A clinical research study at the Havener Eye Institute will examine the responses in patients with keratoconus, glaucoma, ocular hypertension and diabetes, and compare to those with healthy eyes.

Contact the research department to find out if you are eligible for participation at research@osumc.edu.