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Clinical Trials

Department of Ophthalmology physician investigators are currently involved in a number of projects, encompassing a wide range of ophthalmologic specialties, including vitreoretinal disorders, glaucoma, corneal diseases and eye pathology. 

Future plans include participation in more and varied clinical trials, with additional focus on refractive surgical interventions and treatments for uveitis as well as continued work in the specialty areas listed above. Our goal is to continue to offer research opportunities that will provide innovative treatments as well as explore broader disease processes.

Browse our active clinical trials below, and visit the Clinical Trials Frequently Asked Questions page for more information.

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Trials
Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial
The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethas…
The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a parallel design (1:1:1), randomized comparative trial with an anniversary close-out at the 6 month clinic visit. The primary outcome is percent change in central subfield thickness from the baseline OCT measurement to the 12 week visit.

Inclusion criteria:

Patient level inclusion criterion

  • 18 years of age or older;

    Eye level inclusion criteria - at least one eye must meet all of the following conditions

  • Inactive or minimally active non-infectious anterior, intermediate, posterior or panuveitis, as defined by SUN132 criteria as ≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze grade and no active retinal/choroidal lesions for a minimum of 4 weeks;
  • Macular edema (ME) defined as the presence of macular thickness greater than the normal range for the OCT machine being used (see cut points below), regardless of the presence of cysts, following an intravitreal corticosteroid injection (≥ 4 weeks following intravitreal triamcinolone injection or ≥ 12 weeks following intravitreal dexamethasone implant injection);

    Greater than 300 μm for Zeiss Cirrus Greater than 320 μm for Heidelberg Spectralis Greater than 300 μm for Topcon 3DOCT

  • Baseline fluorescein angiogram that, as assessed by the study ophthalmologist, is gradable for degree of leakage in the central subfield;
  • Best corrected visual acuity (BCVA) 5/200 or better;
  • Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of ≤3 intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable (Note: combination medications, e.g., Combigan, are counted as two IOP-lowering medications);
  • Media clarity and pupillary dilation sufficient to allow OCT testing and assessment of the fundus.
  • Exclusion criteria:

    Patient level exclusion criteria

  • History of infectious uveitis in either eye;
  • History of infectious scleritis of any type in either eye (Note: History of noninfectious scleritis that has been active in past 12 months is an eye-level exclusion -see #13 below);
  • History of keratitis (with the exception of keratitis due to dry eye) in either eye;
  • History of central serous retinopathy in either eye;
  • Active infectious conjunctivitis in either eye;
  • Oral prednisone dose > 10 mg per day (or of an alternative corticosteroid at a dose higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose ≤ 10 mg per day at baseline that has not been stable for at least 4 weeks (note: if patient is off of oral prednisone at baseline (M01 study visit) dose stability requirement for past 4 weeks does not apply);
  • Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks (note: use of systemic methotrexate is acceptable as long as regimen has been stable for at least 4 weeks);
  • Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
  • Known allergy or hypersensitivity to any component of the study drugs;
  • For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial;

    Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions

  • History of infectious endophthalmitis;
  • History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of ≥ 0.9 or any notching of optic nerve to the rim);
  • History of active noninfectious scleritis in past 12 months (Note: History of noninfectious scleritis is acceptable if the last episode of active scleritis resolved at least 12 months prior to enrollment);
  • Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of study ophthalmologist may be significant enough to limit improvement of ME (i.e., causing substantial wrinkling of the retinal surface);
  • Torn or ruptured posterior lens capsule
  • Presence of silicone oil;
  • Ozurdex administered in past 12 weeks;
  • Anti-VEGF agent, intravitreal methotrexate, or intravitreal/periocular corticosteroid administered in past 4 weeks;
  • Fluocinolone acetonide implant (Retisert) placed in past 3 years.
  • Koreishi, AnjumKoreishi, Anjum
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    NCT02623426 STU00205049
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    For more information on this study please contact us:

    Santillanes, Crystal 312 472 3627
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    (xIRB) A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Non infectious Uveitis
    The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfecti…
    The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis in participants failing treatment for active noninfectious uveitis.

    Criteria

    Key Inclusion Criteria:

    • Is diagnosed with active noninfectious intermediate-, posterior-, or pan-uveitis
    • Must have active uveitic disease at the Day 1/Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite 2 weeks of maintenance therapy with oral prednisone (≥ 10 mg/day to ≤ 60 mg/day) or an oral corticosteroid equivalent:

      • Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
      • ≥ 2+ anterior chamber cells per the Standardization of Uveitis Nomenclature (SUN) criteria
      • ≥ 2+ vitreous haze per the National Eye Institute/Standardization of Uveitis Nomenclature (NEI/SUN) criteria
    • No evidence of active tuberculosis (TB), history of prior TB or latent TB meeting the screening criteria

    Key Exclusion Criteria:

    • Elevated intraocular pressures and/or severe glaucoma at screening
    • Confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV)
    • Adults in whom anti-tumor necrosis factor (TNF) therapy has failed in controlling uveitis (as determined by the investigator) or previous exposure to any biologic therapy (except intravitreal anti-vascular endothelial growth factor (VEGF) therapy) with a potential therapeutic impact on noninfectious uveitis within 90 days of Day 1/ Baseline are not eligible to participate

    Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

    Koreishi, AnjumKoreishi, Anjum
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    NCT03207815 STU00205424
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    For more information on this study please contact us:

    Santillanes, Crystal 312 472 3627
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    A Natural History Observation and Registry Study of Macular Telangiectasia Type 2: The MACTEL Study

    Since 2005, a group of scientists and clinicians from around the world have identified and are studying hundreds of persons with MacTel Type 2. Progress has been made to find ways to help pre…

    Since 2005, a group of scientists and clinicians from around the world have identified and are studying hundreds of persons with MacTel Type 2. Progress has been made to find ways to help prevent the condition from developing and to find potential treatment(s) but more work is needed. Special scientists (geneticists) are working to understand if this disorder is inherited (passed down from your parents) and basic scientists are working to understand what happens to the eye tissue inside a MacTel eye.

    The purpose of this study is to identify persons with MacTel Type 2, and their affected family members to create a Registry of persons with MacTel Type 2. This Registry will be used to study participants with MacTel Type 2 now and may be used in the future to identify persons to be in a study that may help find a way to prevent or treat this eye condition. We also wish to keep in contact with persons who have told by their MacTel doctor that they have MacTel Type 2.

    In this document, the word “affected” means that it has been confirmed that you have MacTel Type 2. These persons may also be referred to as “Probands” when they are the first person in the family to be diagnosed with the disorder.

    “Unaffected” means that at this time, there is no evidence of MacTel Type 2.

    1. Must have a confirmed clinical diagnosis of MacTel Type 2.

    2. Must be 18 years of age or older.

    Fawzi, AmaniFawzi, Amani
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    STU00206885
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    For more information on this study please contact us:

    Powell, Emily 312 695 2573
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    A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia type 2

    Brief Summary:

    This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the Renexus® implants in participants w…

    Brief Summary:

    This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the Renexus® implants in participants with macular telangiectasia type 2.

    Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)Sexes Eligible for Study: AllAccepts Healthy Volunteers: No

    Criteria

    Key Inclusion Criteria:

    • Participant must have at least one study eye with a positive diagnosis of MacTel Type 2
    • Participant must have an Inner Segment - Outer Segment Junction Line (IS/OS) Photo Receptor (PR) break in the study eye(s) and en face EZ (area of IS/OS loss) as measured by spectral-domain optical coherence tomography (SDOCT) between 0.16 mm^2 and 2.00 mm^2
    • Participant's best corrected visual acuity is 54 letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart

    Key Exclusion Criteria:

    • Participant received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months
    • Participant has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy for neovascular disease complicating MacTel in either eye
    • Participant has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures or outcome of the study
    • Participant was a study participant in any other clinical trial of an intervention (drug or device) within the last 6 months
    • Participant is pregnant or breastfeeding
    • Participant has a chronic requirement (eg ≥ 4 weeks at a time) for ocular medications

    Fawzi, AmaniFawzi, Amani
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    NCT03319849 STU00206919
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    For more information on this study please contact us:

    Powell, Emily 312 695 2573
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    A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
    This study is being conducted as part of a ser…
    This study is being conducted as part of a series of studies for the clinical development of APL-2 for advanced Age-related Macular Degeneration (AMD) (neovascular AMD and geographic atrophy [GA]). The subject population will be comprised of adult male and female subjects with GA secondary to AMD.Age-related macular degeneration is the leading cause of severe vision loss in people over the age of 65 in the United States and other Western countries. In the United States, about 1.75 million people have the advanced forms of AMD. The early signs of AMD (drusen and pigmentary changes) are common in individuals over age 65 and precede the late stage forms, which are visually devastating. The late stage forms of AMD are classified into either macular neovascularization (neovascular, wet, or exudative AMD) or GA.Geographic Atrophy is a disease characterized by thinning and loss of the retinal pigment epithelium (RPE) and concurrent atrophy of photoreceptors and choriocapillaris. Clinically, GA is characterized by gradually expanding atrophy leaving islands of dead retinal cells in the back of the eye. Although GA can result in significant visual function deficits in reading, night vision, anddark adaptation, and produce dense, irreversible scotomas in the visual field, the initial decline in visual acuity may be relatively limited if the fovea is spared. When the fovea is involved, GA quickly causes blindness.Genetic susceptibility has become increasingly recognized as a risk factor and important contributor to AMD. More than 19 genetic polymorphisms have been demonstrated to influence AMD risk, with as many as 5 of these encoded by genes that modulate the complement system. Inflammatory processes, especially those mediated by complement are thought to play a key role in AMD. It is thought that these may contribute to loss of choriocapillaris, photoreceptors and RPE cells.GA is responsible for approximately 20% of all cases of legal blindness in North America (i.e. BCVA 20/200 or worse) with increasing incidence and prevalence owing to a higher life expectancy. While there is treatment for exudative AMD with anti-VEGF therapies, no approved therapy exists for GA which is usually bilateral and relentlessly progressive. It represents asignificant unmet need as it leads to significant visual impairment and affects more than 5 million people worldwide.Primary Objective:To evaluate the efficacy of APL-2 compared to sham injection in patient with GA secondary to AMD assessed by change in the total area of GA lesions from baseline as measured by FAF.

    The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the worst visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be selected as the study eye.

    Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified.

    • Age ≥ 60 years.
    • Normal Luminance best corrected visual acuity of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/320 Snellen equivalent).
    • Clinical diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the Reading Center.
    • The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:

      • Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively)
      • If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 4a.
      • The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
      • Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.
    • Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
    • Female subjects must be:

      • Women of non-child-bearing potential (WONCBP), or
      • Women of child-bearing potential (WOCBP) with a negative serum pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.
    • Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
    • Willing and able to give informed consent and to comply with the study procedures and assessments.
    • Ocular specific exclusion criteria apply to the study eye only, unless otherwise specified.
      • GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.
      • Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm.
      • Any history or active choroidal neovascularization (CNV), associated with AMD or any other cause, including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on SD-OCT imaging and/or fluorescein angiography as assessed by the Reading Center.
      • Presence of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function, including but not limited to, uveitis, other macular diseases (e.g. clinically significant epiretinal membrane (ERM), full thickness macular hole or uncontrolled glaucoma/ocular hypertension. Benign conditions in the opinion of the investigator such as peripheral retina dystrophy are not exclusionary).
      • Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
      • History of laser therapy in the macular region.
      • Aphakia or absence of the posterior capsule. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
      • Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
      • Any contraindication to IVT injection including current ocular or periocular infection.
      • History of prior intravitreal injection.
      • Prior participation in another interventional clinical study for intravitreal therapies in either eye (including subjects receiving sham).
      • Prior participation in another interventional clinical study for geographic atrophy in either eye including investigational oral medication and placebo.
      • Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
      • Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the 24-month treatment period unlikely, or would make the subject an unsafe study candidate.
      • Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
      • Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to APL-2 or any of the excipients in APL-2 solution.
    Lyon, A ThayerLyon, A Thayer
    • Map it 259 E. Erie St. Suite 1520
      Chicago, IL
    NCT03525600 STU00208380
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    For more information on this study please contact us:

    Patel, Hinal 312 695 3067
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    A PHASE III, MULTICENTER, RANDOMIZED, VISUAL ASSESSORMASKED, ACTIVE COMPARATOR STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA (PAGODA)

    The purpose of this study is to compare the effects, good or bad, of r…

    The purpose of this study is to compare the effects, good or bad, of ranibizumab when it is delivered by an ocular (eye) implant (also known as the Port Delivery System with ranibizumab, or PDS) versus ranibizumab delivered by injections into the eye as treatment for your DME. The ocular implant releases ranibizumab continuously (without stopping) over a long period of time into the back of your eye, and it can be refilled with fresh ranibizumab by your study doctor. Because the implant continuously releases ranibizumab over time, you may not need additional eye injections to treat your DME. This study will help determine whether ranibizumab delivered continuously through an ocular implant is similar in effectiveness to ranibizumab injections into the eye for treating patients with DME.

    DME, a long-lasting condition, is the most common cause of vision loss among people with diabetes and causes problems in vision such as blurred or wavy vision and colors that appear to be washed out. It is caused by damage to blood vessels in the retina (the light-sensitive layer at the back of the eye) that causes the vessels to leak blood or fluid into the macula (the most sensitive and central part of the retina that gives you sharp vision). DME causes the macula to swell, leading to blurred or wavy vision. A protein called vascular endothelial growth factor (VEGF) is involved in the development and leakiness of damaged blood vessels, which leak blood or fluid in the macula in patients with DME.

    Ranibizumab is a medicine that blocks VEGF, which in turn slows the growth of and leakage from the damaged blood vessels in your eye. In this study, you will either get ranibizumab delivered by the ocular implant with refills every 6 months, which will release ranibizumab continuously over time into the back of your eye, or you will receive monthly injections of ranibizumab into your eye at a dose of 0.5 mg.

    Ranibizumab, given by regular injections into your eye at a dose of 0.3 mg in the U.S. and 0.5 mg in Europe, is approved for the treatment of DME. The Food and Drug Administration (FDA) has not approved a 0.5 mg monthly dose for DME in the U.S. The two doses have been shown in clinical studies to have similar safety and effectiveness results.

    For subjects receiving the ocular implant, the ranibizumab given as a dose of 2 mg in the implant and refilled every 6 months is considered an experimental study drug that will only be given to subjects in this research study. However, the active ingredient, ranibizumab, is the same as that in the approved product.

    The ocular implant is an experimental device, which means the FDA has not approved it to be implanted in the eye for the treatment of DME. The implant is slightly bigger than a grain of rice (see Figure 1 and Figure 2). The ocular implant is covered by the conjunctiva – the thin, clear skin covering the eye and is usually not visible to others because it is hidden by the upper eyelid.

    • 18 years or older
    • Diabetes mellitus (Type 1 or Type 2)
    • HbA1c level of < 10% within 2 months
    • Vision of 20/320 or better
    Gill, Manjot KGill, Manjot K
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    NCT04108156 STU00210925
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    For more information on this study please contact us:

    Powell, Emily 312 695 2573
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