The Ocular Immunology and Uveitis Foundation

Current Research

Dompé

Synopsis:

This a randomized, multicenter, double-masked, vehicle-controlled, parallel group study to evaluate the efficacy of a formulation containing an anti-oxidant of recombinant human nerve growth factor (rhNGH) eye drops versus vehicle in patients with Stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis (NK). Approximately 48 patients are sought for participation in this study at multiple sites. Learn More

Aldeyra

Synopsis:

This a randomized, investigator-masked, comparator-controlled study to evaluate the efficacy of NS2 eye drops in patients with non-infectious anterior uveitis. Approximately 45 patients are sought for participation in this study at multiple sites. Learn More

Novartis LFG316

Synopsis:

This is an open-label, multicenter, proof-of-concept study assessing the use of LFG316 in patients with active active non-infectious intermediate-, posterior-, or panuveitis. Approximately 25 patients with active disease are sought. Learn More

MUST Trial

Synopsis:

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

Aciont DSPV-201

Synopsis:

This is a randomized, parallel group, double-masked, active-controlled clinical trial to evaluate the efficacy, safety and tolerability of dexamethasone sodium phosphate Visulex (DSP-Visulex) system for the treatment of non-infectious anterior uveitis. Approximately 45 eligible subjects will be enrolled in this study. Learn More

MUST Study

Synopsis:                                                                                           

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                                                               

Synopsis:                                                                   

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

Synopsis:

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

 

Other Research ongoing at the Foundation:

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.

  

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.