This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment. Learn More
This study aims to demonstrate the superiority of gevokizumab, a monoclonal antibody directed against IL-1beta, as compared to a placebo in the treatment of patients with active, non-infectious intermediate, posterior, or panuveitis. Approximately 300 patients are sought for participation in this study nationwide. Currently, this study is aimed at active patients; however, a second study aimed at maintaining long-term remission in inactive patients is slated to begin enrollment in late 2012. Learn More
The MUST trial is a randomized controlled clinical trial comparing two treatments for patients with vision-threatening non-infectious intermediate uveitis, posterior uveitis, or panuveitis: local therapy with fluocinolone acetonide intraocular implant in affected eyes; versus standard therapy: systemic corticosteroid therapy supplemented, when indicated, by corticosteroid-sparing potent immunomodulator therapy.
The initial portion of the study has concluded; all patients nationwide are now enrolled in the “Follow-Up” portion. As part of the clinical trial, patients had an unprecedented amount of clinical information collected longitudinally, which provides a starting point to evaluate the long-term outcomes of patients with these severe forms of uveitis. The objectives of the MUST Trial Follow-up Study are to evaluate long term consequences of the alternative treatment regimens and to conduct broad outcomes research in this well-documented cohort. Learn More
Santen Sirolimus DE-109 Injectable Study
This is a multinational, multicenter, randomized, double-masked study assessing the safety and efficacy of three doses of DE-109 (44 μg, 440 μg, 880 μg) administered every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye. Approximately 500 subjects with active, non-infectious posterior, intermediate or panuveitis will be enrolled at approximately 150 sites. Learn More
Novartis LFG Study
This is an openlabel, multicenter, proof-of-concept study assessing the use of LFG316 in patients with active multifocal choroiditis and panuveitis. Approximately 25 patients with active disease are sought. Learn More
EyeGene, Macula Risk Testing Study
This study is aimed to prognostically test Patient's DNA for an identified early or intermediate age-related macular degeneration gene for likelihood of progression to advanced age-related macular degeneration with vision loss. The testing identifies four known genetic markers/mutations, and evaluates risk based on these results and the patient’s smoking status. The test boasts a 99.9% accuracy rate, and 83% predictive value. Learn More
Other Research ongoing at the Foundation:
Comparison of the Ex-PRESS Glaucoma Filtration Device with the Ahmed Glaucoma Valve in Uveitic Glaucoma
The purpose of this internal study is to long-term safety and efficacy of the Ex-PRESS glaucoma filtration device with the Ahmed glaucoma valve in patients with uveitic glaucoma. Glaucoma is a well-known complication or consequence of uveitis, and medical therapy alone often fails to reach or maintain target intraocular pressures (IOPs). Trabeculectomy have been used to minimize damaging fibrosis; however, postoperative inflammation in uveitic eyes can result in failure.
Two valves under study, the Ex-PRESS and the Ahmed, have both been approved by the FDA for use in glaucoma patients, and both are efficacious in lowering intraocular pressure. This study aims to compare the success rates of these two valves, through the measurement of quantity of glaucoma medications, adverse event assessment, the need for additional surgeries, and IOP.
Eligible patients will be those individuals under consideration for shunt placement. They will be randomized to either device, and followed for approximately 6 months of testing, and 2 years of safety evaluation. Visits are paired with routine follow-up visits, and include standard testing, typical to surgical follow-up. Approximately 50 patients are needed for this study.
Morphometric Analysis of the Corneal Endothelium after Intravitreal Methotrexate for Intraocular Lymphoma
Since intraocular lymphoma was first recognized almost 60 years ago, its treatment has gradually evolved. In the early years, enucleation was often performed. Since that time, radiation therapy alone, systemic chemotherapy alone, or a combination of the two, have been used extensively. Because of the limited intraocular penetration of drugs administered systemically, the systemic and local toxicity of chemotherapy and radiation therapy, and the high rate of recurrence, intravitreous chemotherapy, mainly using methotrexate, has become popular in the last decade, with encouraging results.
The general objective of this study is to assess the safety of the current dose of intravitreal methotrexate injections to the corneal endothelium by comparing the specular microscopy and pachymetry readings before and after intravitreal methotrexate injection for intraocular lymphoma. The best-corrected visual acuity and intraocular pressures before and after injection will also be compared. The lens status of the eye as well as the number of injections per eye will also be reported in this study.
Eligible patients will be age 18 and up, and have confirmed primary or secondary intraocular lymphoma, with scheduled methotrexate intravitreal injections. Different injection schedules, as determined by the Principal Investigator are possible, and will take approximately 9 months to complete. The follow-up period for this study is 6 months, and additional care, as mandated by the study protocol, include specific central corneal specular microscopy and pachymetry measurements. No other responsibilities are required of study participants
Characterization of inflammatory cytokines in the serum and intraocular fluid of patients with ocular inflammatory disease
This special interest study aims to correlate specific pathogenic cytokines found in serum and intraocular fluid with disease status, clinical remission, IMT-independent remission, and relapse. Also, comparisons will be made between cytokine levels in serum and intraocular fluid. This study is currently intended for birdshot retinochoroidopathy and sarcoidosis patients; BSRC and Sarcoid are both chronic inflammatory diseases of the eye, mainly affecting Caucasian women in their 50’s. Sarcoidosis can also manifest systemically. The significance of this study relates to the development of a clinical marker needed for testing to ensure remission, or disease inactivity. Remission is important in order to prevent relapse; however, physicians require quantitative, definitive measures of remission status to improve patient outcomes.
Eligible patients will be diagnosed with birdshot retinochoroidopathy or sarcoidosis. Patients undergoing major or minor intraocular surgical procedures will be contacted to inquire of their willingness to participate, to minimize unnecessary fluid withdrawals. Withdrawal of intraocular fluid is routinely collected in these procedures and discarded; in the case of this study, the fluid would be analyzed. Additionally, blood will be drawn from these patients.
Study participation is limited to one visit, and is paired with routine ocular visits and/or surgical procedures at MERSI. No additional visits or tasks are required.
Standardization of Uveitis Nomenclature (SUN) Project
The SUN Project is a global effort to establish classification criteria for uveitic syndromes. In November, 2004, a group of international uveitis specialists met in Baltimore, USA under the auspices of the International Uveitis Study Group and American Uveitis Society, to standardize the methods for reporting clinical data in the field of uveitis. Their full report was published in the American Journal of Ophthalmology in 2005. This was the most cited article from the American Journal of Ophthalmology for 2006 and 2007. A grant from the National Eye Institute furthered this group’s efforts, by allowing another SUN workshop to take place in Miami in February, 2010. This workshop involved using an informatics approach for the classification of uveitis syndromes.
This work continues at MERSI; information about patients seen here is submitted to the group, along with professional grading, in order to continue this project’s vital efforts for universal, comprehendible language. This is a necessary step to move uveitis research forward.
Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study
This study will evaluate whether therapy that suppresses the immune system given to treat inflammatory diseases of the eye is associated with a greater risk of death and of cancer. Inflammatory diseases of the eye, including uveitis, scleritis, and mucous membrane pemphigoid, are major blinding diseases. For some patients, treatment with corticosteroids is not enough to control the diseases. Researchers expect to gain information about whether immunosuppressive therapy is suitable for patients and which pharmacologics should be avoided. Also, the study will evaluate the frequency of short-term complications with immunosuppressive therapy, as well as the benefits therapy can bring to treatment of eye diseases, and will provide a rich database for studies evaluating outcomes of ocular inflammatory diseases.
Medical charts of patients up to age 65 (median age range of 21 to 65) who have had an inflammatory, noninfectious eye disease are examined for this study. A database is currently in use, and is growing through chart review of patients seen in the uveitis clinic of the National Eye Institute since 1977 and three other sites, one of which being MERSI. Patients who are considered exposed to immunosuppressive therapies are compared with two groups: the general U.S. population and an internal group of patients with the same inflammatory eye diseases who did not receive immunosuppression. Data regarding about 10,000 to 15,000 patients is in the process of collection. The incidence of cancer, the outcomes of immosuppressive therapy as measured by control of the eye disease, visual sharpness, changes in the use of corticosteroids, and rates of remission, are all examined as part of this comprehensive medical record review. Also examined are medical charts of a control group of patients who did not receive immunosuppressive therapy for their uveitis. Approximately 8,000 patients are expected to be included in this study, and followed retrospectively for up to 25 years for mortality (death), using the National Death Index.
Many patients with ocular inflammation can be treated with topical, periocular, or oral corticosteroids. However, for some patients, supplementary immunosuppression with antimetabolite, T-cell inhibitor, and/or alkylating agent therapies is required to control inflammation without causing excessive side effects. Studies of patients with severe immunologic or other systemic diseases suggest that such treatments may result in an increased risk of cancer and other diseases. However, it is unknown whether the increased risk is the result of these treatments or the underlying systemic diseases.
The study is funded by the National Eye Institute. John Kempen, MD, PhD., is the Principal Investigator of the SITE Study
A Retrospective Review of Ocular Inflammatory Disease
Clinical researchers utilize different tools when conducting research, specifically pertaining to the population at hand. A popular tool commonly utilized is known as a “retrospective cohort review”, or the process by which a researcher compares two groups of patients, both with and without a certain disease/outcome, and incorporates other known knowledge, such as risk factors, specific health status, etc. This type of research is especially important for uveitis, which is a rare disorder respectively. Retrospective cohort studies allow researchers to examine smaller populations and analyze possible connections; these studies are relatively quick and allow for analysis of multiple outcomes, where prospective studies are greatly limited by these two factors.
Dr. Foster and staff perform these studies routinely, in order to address connections we’ve seen here at MERSI, and present them to the medical field. Conclusions drawn from these studies are limited; however, they serve as a key initiation step in elucidation of disease processes and biochemical plausibilities.
These studies, once completed, are typically seen in published journals. Information of patients is used, but never identified in the literature or analysis, and access to data is only granted to authorized personnel. Patients are only referred to by unique identifiers in writing manuscripts and analyzing data.