Clinical Trials

Clinical Trials & Studies

We strive to offer the latest knowledge and cutting-edge medical technology to our patients for treatment of their conditions.  We are actively participating in several FDA sanctioned clinical trials, as well as numerous IRB approved clinical studies.  In patients with complex ocular problems, if indicated, a clinical trial may offer our patients the chance to receive treatments that are not available elsewhere.

Clinical trials are not for everyone.  Patient selection and visits are rigorous to ensure efficacy for the participants.  Patients are extremely carefully monitored to ensure the safety.  The best interest of patients is always our priority and patients will always have direct communications with our study staff.

If you are interested in any of these trials, please contact our Palisades Park office at (201) 461-0021 x125 or yue@mersieye.com.
 

An Open Label, Multi-centered, Randomized Phase 2 Study to Evaluate the Safety, Tolerability and Bioactivity of Subcutaneous ACTH GeL in PAtients with Scleritis (The ATLAS Study)
Protocol ATLAS

The proposed ATLAS Study aims to evaluate the potential role of subcutaneous adrenocorticotropic hormone (ACTH) gel in management of non-infectious anterior scleritis.

Requirements:  Active disease and are receiving no treatment.  Active disease and are receiving prednisone (or equivalent dose of another corticosteroid) or at least 1 other systemic immunosuppressant (all systemic immunosuppressants other than corticosteroids will be discontinued 30 days prior to the first administration of the study drug on Day 0).

Sponsor: Mallinckrodt Pharmaceuticals
Status: Starting enrollment soon

A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Noninfectious Uveitis
Protocol GS-US-432-4097

To evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis, as measured by the changes in vitreous haze (VH) grade in each eye, in anterior chamber (AC) cell grade in each eye, and in logarithm of the minimal angle of resolution (logMAR) best corrected visual acuity (BCVA) in each eye.

Requirements:  Judged to be in good health, as determined by the investigator based on the results of medical history, laboratory screening profile, physical examination, chest x-ray, and 12-lead electrocardiogram performed during Screening.  Male or female subjects who are ≥ 18 years of age. Diagnosed with active noninfectious intermediate-, posterior- or pan-uveitis.

Sponsor: Gilead Sciences, Inc.
Status: Open for enrollment

A Phase 1b, Open-Label, Multiple-Dose, Proof-of-Concept Study to Evaluate the Safety, Tolerability and Pharmacodynamics of AK002 in Patients with Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis
Protocol AK002-005

To evaluate the pharmacodynamics and preliminary efficacy of AK002 in patients with Atopic Keratoconjunctivitis (AKC), Vernal Keratoconjunctivitis (VKC), or Perennial Allergic Conjunctivitis (PAC), as measured by changes in signs and symptoms (compared with baseline).

Requirements:  Male or female aged ≥ 18 and ≤ 80 years at the time of signing the informed consent form. Confirmed diagnosis of AKC, VKC, or PAC and, having at least one of the following symptoms:  itching, photophobia, eye pain, foreign body sensation or eye discharge.

Sponsor: Allakos, Inc.
Status: Open for enrollment

ACTH as a re-emerging therapy for uveitis (The ACTHAR Study): An Open-label, Multi-center, Randomized, Phase II Study of the Safety, and Bioactivity of Two Dose Regimens of Subcutaneous Injections of ACTH Gel in Patients with Non-infectious Uveitis
Protocol ACTHAR

To evaluate the safety and tolerability of 2 different dose regimens of Adrenocorticotropic Hormone (ACTH) gel administered by subcutaneous (SC) injection in patients with non-infectious posterior, intermediate or panuveitis. To evaluate the bioactivity of 2 different dose regimens of ACTH gel administered by SC injection in patients with non-infectious posterior, intermediate or panuveitis.

Requirements:  Age ≥ 21. Have active uveitis, defined as having at least 1+ Vitreous Haze (SUN scale) in study eye.  Best-corrected (ETDRS) visual acuity of 20/20 to 20/400 (approximately 80 to 20 letters) in the study eye.  Best-corrected ETDRS visual acuity of 20/400 or better in the fellow eye (approximately 20 letters).

Sponsor: Mallinckrodt Pharmaceuticals
Status: Open for enrollment

A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients with Non-Infectious Anterior Segment Uveitis
Protocol EGP-437-006

To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the Eyegate II Drug Delivery System (EDGS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

Requirements:  Male or female, ages 12-85, with a diagnosis of unilateral or bilateral non-infectious anterior segment uveitis.

Sponsor: Eyegate Pharmaceuticals, Inc.
Status: Open for enrollment

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
Protocol ADX-102-UV-005

To evaluate the efficacy of ADX-102 Ophthalmic Solution on anterior chamber cell count (ACC), in subjects with non-infectious anterior uveitis.
To evaluate the safety and efficacy of ADX-102 Ophthalmic Solution on the signs and symptoms of anterior uveitis in subjects with non-infectious anterior uveitis.

Requirements:  Male or female subjects aged ≥ 18 years and ≤ 85 years. Presence of 6-50 anterior chamber cells within one field of view as measured with a slit lamp microscope in the study eye(s).

Sponsor:  Aldeyra Therapeutics, Inc.
Status:  Open for enrollment

PEACHTREE:  A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects with Macular Edema associated with Non-Infectious Uveitis
Protocol CLS1001-301

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.

Requirements:  Male or female, ages 18 and older, with diagnosis of non-infectious uveitis, diagnosis of macular edema associated with non-infectious uveitis, and Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters read (20/40 Snellen equivalent), in the study eye.

Sponsor:  Chiltern International, Inc.
Status:  Closed for enrollment

A Study of the Long-Term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-or Pan-uveitis
Protocol M11-327

There is an unmet medical need in non-infectious intermediate-, posterior- and pan-uveitis.  These types of uveitis are at a higher risk for vision loss compared to anterior uveitis.  Patients with these types of uveitis are often treated with chronic corticosteroids.  The use of chronic corticosteroids is linked with predictable long-term side effects.  The objective of this study is to evaluate the long-term efficacy and safety of adalimumab subjects with non-infectious intermediate-, posterior- or pan-uveitis.

Requirements:  Male or female, ages 18-99, subjects must have successfully enrolled in either study M10-880 and either met the endpoint of “Treatment Failure” or completed the study.

Sponsor: AbbVie, Inc.
Status: Closed for enrollment

Study of the Safety, Tolerability, and Bioactivity of Tocilizumab On Patients with Non-infectious UVEITIS:  The STOP-UVEITIS Study
Protocol ML28522

The study is designed to evaluate safety and tolerability of repeated Tocilizumab infusion in patients with non-infectious uveitis, as measured by frequency and severity of adverse events from baseline (BL).

Requirements:  Age ≥ 18.  Have active uveitis, defined as having at least 1+ Vitreous Haze (SUN scale) in study eye.  Best-corrected (ETDRS) visual acuity of 20/20 to 20/400 (approximately 80 to 20 letters) in the study eye. Best-corrected ETDRS visual acuity of 20/400 or better in the fellow eye (approximately 20 letters).

Sponsor: Genentech
Status: Closed for enrollment
 

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Research Sources:

The Ocular Immunology and Uveitis Foundation: A Guide to Ocular Inflammatory Disease webpage.
NEI Office of Science Communications: National Eye Institute webpage