Treatment Trials

52 Clinical Trials for Various Conditions

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Treatment of Non-infectious Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate
Description

BACKGROUND: Uveitis comprises of a group of diseases associated with inflammation of the eye that can lead to vision loss. Some people with uveitis also have macular edema (swelling of the retina at the back of the eye). Uveitis and macular edema are treated with medications and sometimes surgery, but treatment does not always prevent vision loss. Previous research has shown that injections of methotrexate into the eye of people with eye disease other than uveitis can help relieve the inflammation, or swelling, that causes macular edema and can slow visual loss. However, it has not yet been approved as a treatment for macular edema associated with uveitis. OBJECTIVES: To evaluate the safety and effectiveness of methotrexate injections as a treatment for macular edema associated with uveitis. ELIGIBILITY: Individuals at least 18 years of age who have been diagnosed with uveitis and macular edema in at least one eye. DESIGN: * This study requires at least nine visits to the National Eye Institute study clinic over a period of 6 months (24 weeks). * Participants will be screened with a physical and ophthalmic examination, medical history, blood and urine tests, and additional eye and other tests as needed. * Participants will receive a methotrexate injection in a selected treatment eye. After the injection, participants will receive antibiotic eye drops to place in the eye three times a day for the 3 days following the injection, leucovorin (folic acid) drops to place in the eye four times a day for 1 week following the injection, and a dose of folic acid to be taken by mouth the day after the injection. * Participants who tolerate the initial injection may continue to receive injections in their study eye every month for 6 months. After 6 months, participants who show improvement from the injections may be evaluated to receive additional injections every 4 to 8 weeks until researchers end the study.

Conditions

Non-infectious Intermediate and Posterior Uveitis

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

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

Conditions

Intermediate Uveitis, Posterior Uveitis

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

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

POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU
Description

This is a multi-center, randomized, double-masked, proof-of-concept study in patients with Active Noninfectious Intermediate, Posterior, or Panuveitis.

Conditions

Uveitis Posterior Non-Infectious, Uveitis, Intermediate, Noninfectious Panuveitis

Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis
Description

A study to evaluate the safety and efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy.

Conditions

Uveitis, Posterior

Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
Description

The main reason for this study is to see if Acthar Gel can reduce inflammation in the uvea. Also, safety information when using it for this purpose will be collected.

Conditions

Uveitis, Posterior, Uveitis, Intermediate, Panuveitis

Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
Description

An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated with a Fluocinolone Acetonide Intravitreal Implant

Conditions

Uveitis, Posterior

Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis
Description

The purpose of this study is to evaluate the short- and long-term efficacy and safety of Acthar for the treatment of adults with non-infectious retinal vasculitis.

Conditions

Uveitis, Posterior, Vasculitis Retinal

Safety and Preliminary Efficacy Study of V404 PDS in Uveitis
Description

This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis.

Conditions

Uveitis, Posterior, Uveitis, Intermediate

Study Assessing Double-masked Uveitis Treatment
Description

The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.

Conditions

Uveitis; Posterior, Disorder

Prophylactic Anecortave Acetate in Patients With a Retisert Implant
Description

Retisert implant is an effective therapy for controlling inflammation in patients with non-infectious posterior uveitis. One of the major complications of this device is the development of elevated intraocular pressure (IOP) following implantation in 60% of patients. Glaucoma filtering is required in over 30% of patients at 2 years. Anecortave acetate (AA) has been shown to reduce steroid induced elevated IOP. The purpose of this study was to evaluate the ability of prophylactic anterior juxtascleral depot administration of AA to prevent this Retisert induced elevated IOP.

Conditions

Uveitis, Posterior, Glaucoma

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants
Description

This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.

Conditions

Noninfectious Posterior Uveitis

A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
Description

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

Conditions

Uveitis, Posterior, Uveitis, Intermediate, Panuveitis

A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
Description

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

Conditions

Uveitis, Posterior, Uveitis, Intermediate, Panuveitis

Combination Daclizumab/Denileukin Diftitox to Treat Uveitis
Description

This study will determine whether treatment with a combination of the drugs daclizumab and denileukin diftitox can eliminate the need for long-term daclizumab treatment in adult patients with uveitis. Denileukin diftitox kills white blood cells called lymphocytes that cause inflammation and may be the cause of uveitis. Patients 18 years of age and older with uveitis in one or both eyes who are on daclizumab therapy and have not had a disease flareup in 6 months may be eligible for this study. Candidates are screened with a medical history, physical examination, eye examination (including vision test, examination of the front of the eye, and pupil dilation for examination of the retina at the back of the eye), blood tests and a questionnaire about their vision and daily activities. After screening, participants undergo the following procedures: * Daclizumab/ denileukin diftitox treatment. Patients receive their regular dose of daclizumab intravenously (through a vein). The interval between doses is increased by 1 week after each dose. When the doses are 10 weeks apart, the daclizumab is stopped. Patients who experience a flare or uveitis are treated with intravenous denileukin diftitox and possibly local injections of steroids around the eye or increasing or adding other medicines as needed to control the uveitis. * Fluorescein angiography to look for blood vessel abnormalities in the eyes. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina (the back portion of the eye) are taken with a special 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 abnormalities. * Ultrasound and urine tests at enrollment and after 1 year to check kidneys, lymph nodes and pelvic area. * Blood tests at enrollment and every 3-6 months for laboratory and immunology tests and other research tests on blood cells to examine the immune response. * Follow-up visits approximately every 6 weeks for 2 years for repeat examinations to determine the response to treatment and drug side effects.

Conditions

Non-infectious Intermediate and Posterior 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

The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment
Description

The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)

Conditions

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

Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI)
Description

A study to evaluate the safety and efficacy of an FAI insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye.

Conditions

Uveitis, Uveitis, Posterior, Uveitis, Intermediate

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

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

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

Study of the Effectiveness of Ozurdex for the Control of Uveitis
Description

The main purpose of this study is to evaluate whether or not the dexamethasone pellet (Ozurdex®, Allergan, Irvine, CA) can replace oral corticosteroid (e.g. prednisone) in the treatment of active sight-threatening, noninfectious intermediate and/or posterior uveitis in which immunosuppressive drug therapy is indicated. Uveitis is an inflammation inside the eye. Uveitis can decrease patients' vision if it is not treated. The dexamethasone pellet is an implant filled with a corticosteroid medicine. This therapy is approved by the Food and Drug Administration (FDA) for the treatment of intermediate and/or posterior uveitis. In this study investigators want to see if using the implant together with systemic immunosuppressive drug therapy can result in lower ocular side effect profile but is effective enough to replace the use of high-dose systemic corticosteroids in the treatment of active intermediate and/or posterior uveitis. Knowing the effectiveness and safety of these treatments is important because the kinds of uveitis being studied usually need to be treated for many years. This information may help researchers understand uveitis better and may suggest ways of improving treatment. Adult patients with intermediate and/or posterior uveitis for which immunosuppressive drug therapy with high-dose corticosteroid is planned may join.

Conditions

Uveitis, Intermediate, Uveitis, Posterior

Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis
Description

This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.

Conditions

Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis, Noninfectious Uveitis

Study of the Safety, Tolerability, and Bioactivity of Tocilizumab On Patients With Non-infectious UVEITIS: The STOP-UVEITIS Study
Description

In the STOP-UVEITIS study, we propose to evaluate the safety, tolerability, and bioactivity of two doses of Tocilizumab (4mg/kg and 8mg/kg), administered monthly, in patients with non-infectious intermediate, posterior, or panuveitis.

Conditions

Intermediate Uveitis, Posterior Uveitis, Pan-uveitis

Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,
Description

This was a multi-center, randomized, active-controlled, open-label study. Approximately 24 patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy were enrolled. Safety, efficacy, and PK assessments occurred at scheduled visits over a 12-week period. Low-molecular-weight non-steroidal immunosuppressive medications were allowed up to the baseline day as long as the dose had not changed in the 3 weeks prior to baseline, except for corticosteroid doses for which might have changed. Patients responding to treatment were offered up to 6 months of extended treatment. Assessments for safety included laboratory safety tests, ECGs, physical exams, ocular exams, vital signs and the monitoring of adverse events. Study participation varied from a minimum of 3 months to a maximum of 9 months.

Conditions

Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Panuveitis

Intravitreal Sirolimus as Therapeutic Approach to Uveitis
Description

The purpose of this study is to find out about the safety and effectiveness of two different doses the study drug, sirolimus, administered intravitreally in patients with uveitis. The potential effectiveness of sirolimus can be utilized to control inflammation in uveitis and yet avoid the potential complications that are usually associated with the systemic use of the drug and other immunomodulatory therapies. In this study, the investigators will administer sirolimus inside the eye (intravitreally) in one of two doses (440mcg/mcL or 880mcg/mcL). Local administration of sirolimus to the eye is not expected to have effects on the rest of the body. Therefore, it may offer a safer way than the current methods used to control the inflammation caused by non-infectious uveitis.

Conditions

Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis

Sirolimus as Therapeutic Approach to Uveitis
Description

The purpose of this study is to find out about the safety and effectiveness of the study drug, sirolimus, in patients with uveitis and to utilize the potential effectiveness of sirolimus, and yet to avoid the potential complications of systemic use of the drug. In this study, the investigators will administer sirolimus either around (subconjunctival injection) or inside the eye (intravitreal injection). Local administration of sirolimus to the eye is not expected to have effects on the rest of the body. Therefore, it may offer a safer way than the current methods used to control the inflammation caused by non-infectious uveitis.

Conditions

Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis