Treatment Trials

35 Clinical Trials for Various Conditions

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A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis
Description

The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).

Conditions

Uveitis, Posterior, Uveitis, Intermediate, Uveitis

A Study of Brepocitinib in Adults with Active Non-Infectious Non-Anterior Uveitis
Description

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active intermediate, posterior, or pan non-infectious uveitis (NIU).

Conditions

Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Pan Uveitis

A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
Description

The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma

Conditions

Non-infectious Anterior Uveitis, Uveitic Glaucoma

A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis
Description

This is a multicenter, phase 2 trial to explore the efficacy and safety of Izokibep (ABY-035) in treating disease activity in patients with non-Infectious Intermediate, Posterior, Pan-Uveitis with significant disease activity at BL despite treatment with stable doses of corticosteroids (≥7 to ≤40 mg/day oral prednisolon or equivalent).

Conditions

Uveitis

A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
Description

The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis .

Conditions

Non-infectious Anterior Uveitis

Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes
Description

Cytomegalovirus (CMV) is generally a latent and asymptomatic infection in healthy, immunocompetent individuals. In immunocompromised patients CMV is well known to cause a retinitis that can lead to blindness. In immunocompetent patients, however, CMV can cause recurrent inflammation in the front of the eye (anterior uveitis). CMV anterior uveitis produces complications including pain, glaucoma, corneal failure, and vision loss. CMV anterior uveitis is commonly misdiagnosed as a non-infectious anterior uveitis and treated as such, which can beget further complications. Diagnosis requires directed polymerase chain reaction (PCR) testing. While antiviral therapy exists for CMV, identifying the appropriate therapy has been challenging because no randomized trials comparing routes of therapy (particularly oral or topical) have been performed. Oral antiviral therapy of CMV carries blood and kidney side effects that requires laboratory monitoring. Topical therapy has been reported to be effective, but no consensus as to the appropriate drug concentration exists. Here we propose a double-masked randomized controlled clinical trial comparing the efficacy of oral valganciclovir, topical ganciclovir 2%, and placebo for the treatment of PCR-proven CMV anterior uveitis. This pilot study will provide valuable information concerning the treatment of CMV anterior uveitis with oral and topical medications, including effective concentrations and side-effect profile. The information obtained from this study will help inform future larger clinical trials in CMV anterior uveitis.

Conditions

Cytomegalovirus Anterior Uveitis

SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
Description

A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.

Conditions

Non-infectious Anterior Uveitis

Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis
Description

Uveitis is an acute or chronic inflammatory condition of unknown etiology. Although uveitis often responds adequately to topical corticosteroids, there are many patients for which this treatment is either inadequate or not tolerated. A patient with inadequate response to treatment would manifest uveitis activity by slit lamp examination determination of anterior chamber cellularity. Lack of tolerance of therapy commonly manifests as ocular hypertension (greater than 21 mmHg measured by tonometry)complicating chronic topical corticosteroid administration, leading to glaucoma and permanent visual loss. Moreover, systemic corticosteroids may be required at a dose unsafe for chronic administration. In these situations, an immunosuppressive medication is often added as a "steroid-sparing" agent. If and when there is clinical response to the added immunosuppressive, the oral and/or topical corticosteroid dose can be reduced or eliminated to avoid toxicity. There are several reasons for believing that Acthar might be beneficial in the treatment of uveitis patients. In addition to increasing adrenal production or cortisol, Acthar has another important mechanisms of action mediated by its binding of melanocortin receptors. Melanocortin down-regulates activity of B and T lymphocytes, monocytes and macrophages. In animal studies, melanocortin peptides down-regulate T helper cells, up-regulate T Regulatory cells, and decrease B lymphocyte production of B Lymphocyte Stimulator. In macrophages, there is down-regulation of IL-1, IL-2, INF gamma, TNF alpha, nitric oxide and adhesion molecules. In other cells, in addition to IL-10 upregulation (monocytes), there is down-regulation of VACM and ECAM (endothelial cells), prostaglandins (fibroblasts) and MCP-1 and RANTES (renal tubules).CNS mediation of systemic inflammation may also be down-regulated by melanocortin receptor binding by Acthar.

Conditions

Uveitis

Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis
Description

The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

Conditions

Anterior Uveitis

A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
Description

This is a randomized, multi-center, investigator masked, comparator controlled study. The purpose of this study is to determine the efficacy and safety of NS2 in patients with non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%. Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.

Conditions

Non-infectious Anterior Uveitis

Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis
Description

The purpose of this study is to determine the efficacy, safety, and tolerability of dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in patients with acute anterior uveitis.

Conditions

Non-Infectious Anterior Uveitis

Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
Description

The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis.

Conditions

Endogenous Anterior Uveitis

PEMF: an Adjunct Therapy for Anterior Uveitis
Description

The purpose of this study is to determine if a medical device (ActiPatch) that emits a low frequency pulsed electromagnetic field (PEMF) will benefit patients with anterior uveitis. Anterior uveitis (aka iritis) is an inflammatory disease involving the front segment of the eye. This is a common cause of a painful red eye, and ActiPatch has been shown to be effective in treating tissue inflammation. The conventional treatment of iritis typically involves frequent administration of topical steroids which have their own inherent risks (development of cataracts and/or glaucoma). The purpose of this study is to determine if ActiPatch therapy can be used to shorten the length of time and/or quantity of steroids administered.

Conditions

Anterior Uveitis, Iritis

Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis
Description

The purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with non-infectious anterior segment uveitis.

Conditions

Uveitis, Anterior

A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis
Description

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious anterior uveitis

Conditions

Uveitis, Anterior, Panuveitis

A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Anterior Uveitis
Description

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious anterior uveitis.

Conditions

Anterior Uveitis

Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis
Description

The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

Conditions

Anterior Uveitis

Topical Interferon Gamma for Macular Edema Secondary to Uveitis
Description

The objective of this study is to investigate the safety and efficacy of ocular instillations of interferon gamma-1b as a potential treatment for cystoid macular edema (CME) secondary to uveitis.

Conditions

Anterior Uveitis, Uveitis

Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti
Description

Background: * Uveitis is an inflammatory condition in which the patient's own immune system attacks the eye, causing eye inflammation and vision loss. Patients with uveitis may be treated with immunosuppressive medications to reduce the inflammation and prevent vision loss. * Sirolimus is an immunosuppressive medication that is approved by the U.S. Food and Drug Administration (FDA) to prevent organ rejection following a kidney transplant. Researchers think that sirolimus may affect the part of the immune system that may be an important cause of uveitis, and may decrease the inflammation that causes uveitis. * In this study, sirolimus will be given as an injection under the outer layer of your eye. The FDA has permitted the investigational use of sirolimus for this study. Objectives: * To determine if subconjunctival injection of sirolimus is safe for treatment of uveitis. * To see if sirolimus is an effective treatment for uveitis. Eligibility: * Patients 18 years of age and older with active uveitis in one or both eyes. If a patient has uveitis in both eyes, the one in which the inflammation is worse will be treated during the study. The vision in the study eye must be at least 20/400. * Patients must have good liver function, and must be willing to practice sun protection measures for 2 weeks following the treatment. Design: * Treatment with sirolimus in the study eye: * Antibiotic and numbing eye drops will be given before the sirolimus injection. * 1 dose of sirolimus will be injected directly into the subconjunctiva (white part of the eye). * Antibiotic drops will be given for topical application 3 times per day for 2 days after the injection. * Patients will be followed for 16 weeks after sirolimus injection (initial visit and follow-up visits in Weeks 2, 4, 8, 12, and 16). * Evaluations during the treatment period and follow-up visits: * Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. * Full medical and ophthalmic history, involving questionnaires and discussion with researchers. * Eye examination, dilation, and photography, including measurements of retinal thickness and fluorescent dye tests of blood flow in the eye. * Blood and urine tests. * Because of the increased risk of skin cancer associated with sirolimus, patients ...

Conditions

Anterior Uveitis

Quality of Life and Visual Function in Uveitis Patients
Description

The purpose of this study was to measure the quality of visual function and quality of daily living in patients with anterior, posterior, and panuveitis.

Conditions

Anterior Uveitis, Posterior Uveitis, Panuveitis, Uveitis

Human Anti-Tac (Daclizumab) to Treat Juvenile Idiopathic Arthritis (JIA)-Associated Uveitis
Description

This study will examine the safety and effectiveness of a monoclonal antibody called humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis (JIA). Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. The HAT antibody is designed to prevent a specific chemical interaction needed for immune cells to produce inflammation. Current treatments for uveitis include steroids and immune-suppressing drugs. These treatments do not always work or they may cause significant side effects. This study will determine whether daclizumab can improve uveitis in children and reduce the need for other medicines. Patients between 6 and 18 years of age with active non-infectious JIA-associated uveitis requiring treatment with anti-inflammatory medications as often as three times a day or more may be eligible for this study. Each candidate is screened with a medical history, physical examination, blood tests, eye examination, and the following specialized tests: * Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating the presence of inflammation. * Optical coherence tomography to measure retinal thickness. The eyes are examined through a machine that produces cross-sectional pictures of the retina. These measures are repeated during the study to determine changes, if any, in retinal thickening. * Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to examine and photograph the back of the eye. Upon entering the study, participants receive a 90-minute infusion of daclizumab through a catheter (plastic tube) placed in an arm vein. They return to the clinic after 14 days and again after 28 days for repeat eye examinations, blood tests, and daclizumab infusions. Four weeks after the third infusion, patients are examined for response to treatment. Those who have benefited from daclizumab may continue receiving monthly infusions of the drug for up to one year. A blood test and eye examination are done at the time of each infusion. Patients whose disease has remained active 12 weeks after the first infusion are taken off the study and treated with other medications.

Conditions

Anterior Uveitis, Arthritis, Juvenile Idiopathic, Iritis, Immunosuppression

Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients
Description

Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory reaction involving ocular tissue and vasculature. The inflammation usually causes pain, redness, photophobia and blurred vision. This inflammation, is typically treated with regional or systemic therapy. The regional therapy typically consists of topical corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to evaluate the possible effectiveness of H.P. Acthar in patients with active ocular inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.

Conditions

Uveitis, Anterior Uveitis, Intermediate Uveitis, Posterior Uveitis, Scleritis, Clinically Significant Macular Edema

Ocular Sarcoidosis Open Label Trial of ACTHAR Gel
Description

Treatment with ACTHAR Gel will result in a reduction of ocular inflammation in patients with active ocular sarcoidosis that requires systemic immunosuppressant therapy (hypothesis)

Conditions

Ocular Sarcoidosis, Panuveitis, Anterior Uveitis

Evaluation and Treatment of Patients With Inflammatory Eye Diseases
Description

This study offers evaluation and treatment for patients with inflammatory eye diseases, such as uveitis. The protocol is not designed to test new treatments; rather, patients will receive current standard of care treatments. The purpose of the study is twofold: 1) to allow National Eye Institute physicians to increase their knowledge of inflammatory eye conditions and identify new avenues of possible research in this area; and 2) to establish a pool of patients who may be eligible for new studies as they are developed. (Participants in this protocol will not be required to join a new study; the decision will be voluntary.) Children and adults with uveitis and other inflammatory eye diseases may be eligible for this study. Candidates will be screened with a medical history, brief physical examination, thorough eye examination and blood tests. The eye examination includes measurements of visual acuity (ability to see the vision chart), eye pressure and dilation of the pupils to examine the lens and retina (back part of the eye). Patients may also undergo the following procedures: 1. Fundus photography - Special photographs of the inside of the eye to help evaluate the status of the retina and evaluate changes that may occur in the future. From 2 to 20 pictures may be taken, depending on the eye condition. The camera flashes a bright light into the eye for each picture. 2. Fluorescein angiography - Procedure to evaluate the eye's blood vessels. A yellow dye injected into an arm vein travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. Participants will be followed at least 3 years. Follow-up visits are scheduled according to the standard of care for the individual patient's eye problem. Vision will be checked at each visit, and some of the screening tests described above may be repeated to follow the progress of disease and evaluate the response to treatment.

Conditions

Choroiditis, Iridocyclitis, Iritis, Retinal Disease

Adalimumab in JIA-associated Uveitis Stopping Trial
Description

The proposed study is a stratified, block-randomized, double-masked, controlled trial to determine the feasibility of discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU).

Conditions

Uveitis, JIA

Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis
Description

This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema.

Conditions

Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis

MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301
Description

This study is a non-interventional, observational extension of the Parent study, CLS1001-301 (NCT02595398). The purpose of this study is to characterize the continued clinical benefit(s) regarding safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide injectable suspension, for the treatment of macular edema associated with non-infectious uveitis.

Conditions

Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis

Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
Description

The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.

Conditions

Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis

Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
Description

The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.

Conditions

Uveitis, Macular Edema, Uveitis, Posterior, Uveitis, Anterior, Panuveitis, Uveitis, Intermediate

Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study
Description

The objective of this study is to explore the efficacy of ixekizumab in treating patients with a diagnosis of non-infectious intermediate, posterior, panuveitis, or chronic steroid-dependent anterior uveitis who had failed treatment with a classic synthetic DMARD including methotrexate, mycophenolate, cyclosporin, azathioprine, cyclophosphamide and/or at least one anti-TNF agent including adalimumab, infliximab, etanercept, golimumab or certolizumab.

Conditions

Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis