Ronald C. Gentile, MD and Richard B. Rosen, MD lead a committed Retina research Division aimed at the experimentation and development of new diagnostic and therapeutic modalities for diseases of the retina, vitreous and macula. Together spearheads the development and use of innovative treatments including combination therapies for macular degeneration, diabetic retinopathy and retina vein occlusions, anti-proliferative agents to prevent proliferative vitreoretinopathy, ocular trauma, and long acting anti-inflammatory agents for chronic severe vitreous hemorrhage.
Clinical Trials Drug Studies
Research in Age-related Macular Degeneration
Age-related macular degeneration (AMD) is the leading cause of blindness in non-Hispanic whites over the age of 65 years in developed countries. AMD is a progressive and chronic disease that gradually destroys the architecture and function of the retina. In some patients, progression of AMD to an advanced form can lead to loss of central vision.
Two new innovative medications are currently being tested. The first is an eyedrop medication as a treatment for neovascular AMD based on inhibition of VEGF and PDGF signaling pathways which will stop the progression of existing lesions and halt neovascularization, both of which otherwise could lead to central vision loss. The second medication is a novel anti angiogenic agent delivered by an injection into the vitreous. This drug designed as a specific antagonist that binds, "Trap" and inactivates circulating VEGF in the blood stream and interferes with the growth of new blood vessels that lead to retinal edema, ischemia and hemorrhage in diseases of ocular neovascularization.
Research in Diabetic Retinopathy
A significant ocular condition called diabetic macular edema or "DME" causes swelling in the center of the retina (the light-sensitive lining inside of the back of the eye) from diabetes. We are doing a study to find out if an injection of a drug directly into the eye either alone or combined with laser treatment is better than the standard of care laser treatment alone for DME. There are two drugs that will be used in the study. They are called ranibizumab (an angiogenic agent) and triamcinolone acetonide (corticosteroid).
National Institutes of Health Studies
Diabetic Retinopathy Clinical Research Network (DRCRnet) - National Eye Institute
We are currently involved in NEI sponsored clinical trials in collaboration with the DRCR Network.
DME Treatment Trial
This randomized multi center, national trial's main purpose of the study is to find out which is a better treatment for DME: laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone. This will be an important contribution to establish the safest and most efficacious treatment for diabetic macular edema.
Diabetic Retinopathy Treatment Trial
Diabetic retinopathy (DR) remains the leading cause of visual loss and new-onset blindness in the United States for those 20 through 74 years of age. Given the aging US population and the concomitant increasing age-specific prevalence of diabetes, the public health impact of Diabetic Retinopathy is enormous.
This randomized multi center, national study is being conducted to determine whether intravitreal injection of an anti-VEGF drug or an intravitreal injection of a corticosteroid can reduce the risk of visual acuity impairment that can occur following PRP and increase the chances of at least short-term visual acuity improvement in eyes with evidence of center-involved macular edema that are undergoing PRP for severe Non proliferative or Proliferative DR.
Visual Acuity Trial
Visual acuity is a common primary outcome measure in clinical research of eye diseases and has been the primary outcome measure in all of the phase 3 clinical trials conducted by the New York Eye and Ear Infirmary of Mount Sinai. Since, visual acuity is the primary outcome variable in the major Diabetic Retinopathy Clinical Research Network (DRCR.net) trials, it is important to have additional test-retest data in individuals with diabetic retinopathy and across a large number of centers. The Einhorn research center, clinical trials department proudly includes certified researchers and technicians with varying levels of overall experience in manual refraction and optometric testing.
Comparison of Time Domain OCT and Spectral Domain OCT Retinal Thickness Measurement in Diabetic Macular Edema Trial
This selective center study is being conducted to compare thickness measurements between Zeiss Time Domain (TD) Stratus OCT and selected SD OCT machines (Zeiss Cirrus, Heidelberg Spectralis, and Topcon 3D-OCT), estimating a conversion factor between TD OCT and SD OCT. The results will be reviewed by a reading center which will assess and compare the reproducibility of the selected SD OCT machines utilizing their respective software analysis algorithms. This study will set a standard for all upcoming SD OCT specifications in future clinical trials research.
Age-Related Eye Disease Study 2 (AREDS 2) - National Eye Institute
In this study, we examine Nutrient-based preventive treatments for AMD development and progression. This is a NEI-sponsored, multi-center Phase III randomized clinical trial designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 LCPUFAs as a treatment for AMD, cataract and moderate vision loss. In addition to this objective, the study will provide information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals include the evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS formulation on the progression and development of AMD. This trial will contribute to a compelling need to explore the benefits and risks on nutrients that are both concentrated in the retina and implicated in modulation of pathogenic factors and processes of AMD.
eyeGENE - National Ophthalmic Disease Genotyping Network - National Eye Institute
EyeGENE is a formation of a national collaborative network for ophthalmic research and diagnostic genotyping. This is a coordinated effort could and should be made to establish a community resource for ophthalmic genetic disease. This resource would include patient access to diagnostic genotyping, genetic counseling and information services, a patient database that would be shared among researchers, and a genetic specimen repository. The participants predicted that this resource would benefit patients by providing medically useful information and at the same help to speed research into treatments for these conditions. In this study we are examining congenital disorders that causes blindness, neurodegeneration, cone-rod dysfunction, retinoblastoma, X-linked eye disorders, optic atrophy, and other rare eye disorders.
The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study - National Eye Institute
This multi center, national trial compares visual acuity outcome among 3 groups of participants: those who are randomly assigned to receive standard care and those randomly assigned to receive one of two doses of intravitreal injection(s) of triamcinolone acetonide for treatment of macular edema associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). Currently there is only the standard laser treatment for BRVO and no standard treatment for CRVO. We anticipate the results of this study will meet the medical need to provide patients with vein occlusions additional treatments without significant side effects.
Sponsored Studies - 2009-2010
A Natural History of Macular Telangectasia - The MActel Study
This a foundation grant to study and follow for 5 years the natural history and genetics of patients with Macular telangiectasis. Retinal telangiectasis is a group of rare, idiopathic, congenital retinal vascular anomalies affecting the retinal capillaries in which irregular capillary dilation and incompetence occur in the macula with or without vascular changes in the retinal periphery. The pathogenesis of macular telangiectasia is unknown. Therefore the information learned from this project will be disseminated to help the Macular Telangiectasia community better understand the natural course of the disease which could possibly lead into pilot drug therapies.
This trial studies multi-centered randomized trial looks at fenretinide [N-(4-hydroxyphenyl) retinamide] for the treatment of GA in subjects with AMD. GA usually causes a gradual loss of vision, with significantly decreased visual function in dim lighting and delayed dark adaptation. Reading is appreciably impaired in GA, as is the ability to drive and recognize faces. We are evaluating whether fenretinide can prevent further vision function loss in the advanced AMD stages.
Anti-Angiogenic Therapy Study
The first eyedrop medication clinical study as a treatment for neovascular AMD based on inhibition of VEGF and PDGF signaling pathways which will stop the progression of existing lesions and halt neovascularization, both of which otherwise could lead to central vision loss. We are currently recruiting patients in this study.
VEGF Trap Study
This drug designed as a specific antagonist that binds, "Trap" and inactivates circulating VEGF in the blood stream and interferes with the growth of new blood vessels that lead to retinal edema, ischemia and hemorrhage in diseases of ocular neovascularization. We are currently evaluating the data in this study.
Near Infra Red Treatment for AMD and DME Study
This study looks at Near-infrared light (NIR) via light-emitting diodes (LED) treatment promotes retinal healing and improve visual function following high intensity laser retinal injury by augmenting cellular energy metabolism, enhances mitochondrial function, increases cytochrome C oxidase activity, stimulates antioxidant protective pathways, and promotes cell survival. LED directly benefits injured neurons in the retina, the lateral geniculate nucleus, and the visual cortex, where perception occurs. From a public health perspective, a Light-Emitting Diode (LED) Array study is important to conduct because it has been approved as a non-significant risk (NSR) device for treatment of eye disorders, it has a low cost of treatment, and it may serve as an effective, non-invasive alternative or adjunctive treatment to Anti-VEGF, the current standard of care for AMD.
Also known as fundus perimetry, microperimetry is a new technique which allows for exact topographic correlation between portions of the central retina and their light sensitivity. The principle rests on the possibility to see —in real time— the retina under examination by infrared light and to project a defined light stimulus over an individual, selected location. Microperimetry allows quantification of retinal threshold in the macular area. Sequential examinations allow evaluation of the natural history of disease, and monitoring of the effect of therapeutic intervention.
We are using this tool to image in fine detail early macular visual field defects in the central fixation area, especially common in age related macular degeneration, and to monitor both their progression and the response to treatment. Our studies have shown that the microperimetry is a key source in early diagnosis and detection of AMD even before symptoms appear.
Retinal Functional Imaging
This new device is the only commercially available technology that provides real-time calculation of the velocity of the retinal blood flow. By using a sequence of high-quality photographs of the retina and its vessels, the device measures the velocity of each red cell and based on the caliper of the vessels one can estimate the blood supply at each retinal region, such as the macular or parapapillary retina. This is particularly useful to understand the role of blood flow and pre and post surgical treatment that could potentially prevent macular and glaucomatous visual loss.
Retina Genetics Research
A significant breakthrough in 2005 was the discovery of genetic polymorphisms or mutations that have been or may be found to be associated with AMD, specifically the Y402H nucleotide CFH polymorphism allele. We are investigating the frequency of the genes associated with AMD in white and in non-white populations with and without AMD. We are also exploring whether patients currently on treatment involving anti-inflammatory medications such as triamcinolone and anti-VEGF inhibitors such as Macugen, Lucentis and Avastin may have a greater beneficial effect on patients with the gene associated with AMD versus those patients without the allele.
The Advanced Retinal Imaging Center encompasses virtually the most cutting-edge imaging technology in one institute. Its goal has been to explore new technologies for imaging the human retina in order to enhance our understanding of the anatomy, physiology and visual function for the benefit of our patients, as well as our general understanding. Research instrumentation includes Preferential Hyperacuity Perimeter, optical coherence tomography, time-domain OCT, Canon Laser Blood Flowmeter, modified HRA Macular Pigment Densitometer and Retinal Function Imager. The Spectral OCT SLO is the first and only Spectral OCT/SLO system to combine structural OCT and functional Microperimetry testing for examination of the retina. The Einhorn Research Center encompasses a multitude of ultra-high speed image acquisition that allows better repeatability of measurements contributing to detecting change (worsening) more accurately and efficiently.