Department of Ophthalmology physician investigators are currently involved in a number of projects, encompassing a wide range of ophthalmologic specialties, including vitreoretinal disorders, glaucoma, corneal diseases and eye pathology.
Future plans include participation in more and varied clinical trials, with additional focus on refractive surgical interventions and treatments for uveitis as well as continued work in the specialty areas listed above. Our goal is to continue to offer research opportunities that will provide innovative treatments as well as explore broader disease processes.
Browse our active clinical trials below, and visit the Clinical Trials Frequently Asked Questions page for more information.
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Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial
The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethas…
The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a parallel design (1:1:1), randomized comparative trial with an anniversary close-out at the 6 month clinic visit. The primary outcome is percent change in central subfield thickness from the baseline OCT measurement to the 12 week visit.
Patient level inclusion criterion
18 years of age or older;
Eye level inclusion criteria - at least one eye must meet all of the following conditions
Macular edema (ME) defined as the presence of macular thickness greater than the normal range for the OCT machine being used (see cut points below), regardless of the presence of cysts, following an intravitreal corticosteroid injection (≥ 4 weeks following intravitreal triamcinolone injection or ≥ 12 weeks following intravitreal dexamethasone implant injection);
Greater than 300 μm for Zeiss Cirrus Greater than 320 μm for Heidelberg Spectralis Greater than 300 μm for Topcon 3DOCT
Patient level exclusion criteria
For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial;
Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions
A Natural History Observation and Registry Study of Macular Telangiectasia Type 2: The MACTEL Study
Since 2005, a group of scientists and clinicians from around the world have identified and are studying hundreds of persons with MacTel Type 2. Progress has been made to find ways to help pre…
Since 2005, a group of scientists and clinicians from around the world have identified and are studying hundreds of persons with MacTel Type 2. Progress has been made to find ways to help prevent the condition from developing and to find potential treatment(s) but more work is needed. Special scientists (geneticists) are working to understand if this disorder is inherited (passed down from your parents) and basic scientists are working to understand what happens to the eye tissue inside a MacTel eye.
The purpose of this study is to identify persons with MacTel Type 2, and their affected family members to create a Registry of persons with MacTel Type 2. This Registry will be used to study participants with MacTel Type 2 now and may be used in the future to identify persons to be in a study that may help find a way to prevent or treat this eye condition. We also wish to keep in contact with persons who have told by their MacTel doctor that they have MacTel Type 2.
In this document, the word “affected” means that it has been confirmed that you have MacTel Type 2. These persons may also be referred to as “Probands” when they are the first person in the family to be diagnosed with the disorder.
“Unaffected” means that at this time, there is no evidence of MacTel Type 2.
1. Must have a confirmed clinical diagnosis of MacTel Type 2.
2. Must be 18 years of age or older.
A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia type 2
This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the Renexus® implants in participants w…
This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the Renexus® implants in participants with macular telangiectasia type 2.
Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)Sexes Eligible for Study: AllAccepts Healthy Volunteers: No
Key Inclusion Criteria:
Key Exclusion Criteria:
A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
This study is being conducted as part of a ser…
This study is being conducted as part of a series of studies for the clinical development of APL-2 for advanced Age-related Macular Degeneration (AMD) (neovascular AMD and geographic atrophy [GA]). The subject population will be comprised of adult male and female subjects with GA secondary to AMD.Age-related macular degeneration is the leading cause of severe vision loss in people over the age of 65 in the United States and other Western countries. In the United States, about 1.75 million people have the advanced forms of AMD. The early signs of AMD (drusen and pigmentary changes) are common in individuals over age 65 and precede the late stage forms, which are visually devastating. The late stage forms of AMD are classified into either macular neovascularization (neovascular, wet, or exudative AMD) or GA.Geographic Atrophy is a disease characterized by thinning and loss of the retinal pigment epithelium (RPE) and concurrent atrophy of photoreceptors and choriocapillaris. Clinically, GA is characterized by gradually expanding atrophy leaving islands of dead retinal cells in the back of the eye. Although GA can result in significant visual function deficits in reading, night vision, anddark adaptation, and produce dense, irreversible scotomas in the visual field, the initial decline in visual acuity may be relatively limited if the fovea is spared. When the fovea is involved, GA quickly causes blindness.Genetic susceptibility has become increasingly recognized as a risk factor and important contributor to AMD. More than 19 genetic polymorphisms have been demonstrated to influence AMD risk, with as many as 5 of these encoded by genes that modulate the complement system. Inflammatory processes, especially those mediated by complement are thought to play a key role in AMD. It is thought that these may contribute to loss of choriocapillaris, photoreceptors and RPE cells.GA is responsible for approximately 20% of all cases of legal blindness in North America (i.e. BCVA 20/200 or worse) with increasing incidence and prevalence owing to a higher life expectancy. While there is treatment for exudative AMD with anti-VEGF therapies, no approved therapy exists for GA which is usually bilateral and relentlessly progressive. It represents asignificant unmet need as it leads to significant visual impairment and affects more than 5 million people worldwide.Primary Objective:To evaluate the efficacy of APL-2 compared to sham injection in patient with GA secondary to AMD assessed by change in the total area of GA lesions from baseline as measured by FAF.
The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the worst visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be selected as the study eye.
Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified.
A PHASE III, MULTICENTER, RANDOMIZED, VISUAL ASSESSORMASKED, ACTIVE COMPARATOR STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA (PAGODA)
The purpose of this study is to compare the effects, good or bad, of r…
The purpose of this study is to compare the effects, good or bad, of ranibizumab when it is delivered by an ocular (eye) implant (also known as the Port Delivery System with ranibizumab, or PDS) versus ranibizumab delivered by injections into the eye as treatment for your DME. The ocular implant releases ranibizumab continuously (without stopping) over a long period of time into the back of your eye, and it can be refilled with fresh ranibizumab by your study doctor. Because the implant continuously releases ranibizumab over time, you may not need additional eye injections to treat your DME. This study will help determine whether ranibizumab delivered continuously through an ocular implant is similar in effectiveness to ranibizumab injections into the eye for treating patients with DME.
DME, a long-lasting condition, is the most common cause of vision loss among people with diabetes and causes problems in vision such as blurred or wavy vision and colors that appear to be washed out. It is caused by damage to blood vessels in the retina (the light-sensitive layer at the back of the eye) that causes the vessels to leak blood or fluid into the macula (the most sensitive and central part of the retina that gives you sharp vision). DME causes the macula to swell, leading to blurred or wavy vision. A protein called vascular endothelial growth factor (VEGF) is involved in the development and leakiness of damaged blood vessels, which leak blood or fluid in the macula in patients with DME.
Ranibizumab is a medicine that blocks VEGF, which in turn slows the growth of and leakage from the damaged blood vessels in your eye. In this study, you will either get ranibizumab delivered by the ocular implant with refills every 6 months, which will release ranibizumab continuously over time into the back of your eye, or you will receive monthly injections of ranibizumab into your eye at a dose of 0.5 mg.
Ranibizumab, given by regular injections into your eye at a dose of 0.3 mg in the U.S. and 0.5 mg in Europe, is approved for the treatment of DME. The Food and Drug Administration (FDA) has not approved a 0.5 mg monthly dose for DME in the U.S. The two doses have been shown in clinical studies to have similar safety and effectiveness results.
For subjects receiving the ocular implant, the ranibizumab given as a dose of 2 mg in the implant and refilled every 6 months is considered an experimental study drug that will only be given to subjects in this research study. However, the active ingredient, ranibizumab, is the same as that in the approved product.
The ocular implant is an experimental device, which means the FDA has not approved it to be implanted in the eye for the treatment of DME. The implant is slightly bigger than a grain of rice (see Figure 1 and Figure 2). The ocular implant is covered by the conjunctiva – the thin, clear skin covering the eye and is usually not visible to others because it is hidden by the upper eyelid.