Northwestern University Feinberg School of Medicine
Department of Ophthalmology
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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.

Trials
Prospective randomized evaluation of centration of intraocular lens with two laser settings for capsulorhexis with femtosecond laser
The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centr…
The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centration and pupil centration. It is hypothesized that scanned capsule centration provides more uniform(25% better) overlap of capsulorhexis margin over IOL optic compared to pupil centration.
Basti, SurendraBasti, Surendra
NCT02315456 STU00081388
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1-855-NU-STUDY
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A Prospective, Double-masked, Placebo Controlled Comparison of Topical 0.15% Ganciclovir Gel (Zirgan®) Versus 0.3% Hypromellose Gel (Genteal Gel®; Placebo) for the Treatment of Herpes Zoster Keratitis While on Oral Anti-viral Treatment
The purpose of this study is to see if ganciclovir gel (Zirgan…
The purpose of this study is to see if ganciclovir gel (Zirgan®) will work better than a lubricating gel placebo in the treatment of herpes zoster dendritic keratitis.
Feder, Robert SFeder, Robert S
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02382588 STU00082890
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Seddon, Nicole 1-855-NU-STUDY
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DRCR V - Treatment for Central-Involved Diabetic macular Edema in Eyes with Very Good Visual Acuity
Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with cen…
Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse) were eligible. Eyes that have central-involved DME with "good" visual acuity (20/25 or better) have not been addressed systematically by recent studies for treatment of DME. Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS) suggest that a substantial percentage of eyes with central-involved DME may retain good vision. The investigators do not know definitively whether eyes with central-involved DME and good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g. aflibercept) therapy initially, or focal/grid laser treatment or observation initially followed by anti-VEGF only if vision worsens. The primary objective of the protocol is to compare the % of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt anti-VEGF. Secondary objectives include: - Comparing other visual acuity outcomes between treatment groups, such as the percent of eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual acuity, percent of eyes with at least 5 letter gain in visual acuity from baseline, mean visual acuity, mean change in visual acuity, adjusted for baseline mean visual acuity - For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF treatment - Comparing optical coherence tomography (OCT) outcomes, such as the mean change in OCT central subfield (CSF) thickness, adjusted for baseline mean thickness - Comparing the number of eyes with PDR at randomization, proportion of eyes avoiding vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR between treatment groups - Comparing safety outcomes between treatment groups - Comparing associated treatment and follow-up exam costs between treatment groups
Lyon, A ThayerLyon, A Thayer
NCT01909791 STU00086556
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1-855-NU-STUDY
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(CIRB)-A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered by Single or Multi-Dose Intravitreal Injection(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
This is a double-masked, randomized, sham-controlled efficacy and safety study th…
This is a double-masked, randomized, sham-controlled efficacy and safety study that will enroll approximately 800 subjects with recent-onset NAION. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive QPI-1007 and/or a sham procedure. Subjects will have a two in three (66%) chance of receiving active treatment (no sham procedure) and a one in three (33%) chance of receiving sham procedure (no active treatment). Total study time involvement is approximately 12 months.

Key Inclusion Criteria:

  • Positive diagnosis of first episode of NAION in the study eye with symptom onset within 14 days prior to planned study drug administration/sham procedure
  • Best corrected visual acuity score in the study eye is better than or equal to 15 letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study drug administration/sham procedure.
  • Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus examination

Key Exclusion Criteria:

  • Present use or history of any treatment for the current episode of NAION, including systemic steroids, brimonidine, or traditional Chinese herbal medicine
  • Prior episode of NAION in the study eye only
  • Present use of drugs known to cause optic nerve or retinal toxicity at Day 1/Randomization, such as: chloroquine or hydroxychloroquine, ethambutol, Vigabatrin. Subjects who need to be prescribed any of these drugs during the course of the study will be discontinued from the trial.
  • Any medical condition, concomitant therapy, or previous incisional or laser surgery that, in the opinion of the Investigator, would preclude IVT injection in the study eye only
  • Clinical evidence of temporal arteritis
Volpe, NicholasVolpe, Nicholas
  • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
    Chicago, IL
NCT02341560 STU00202830
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Santillanes, Crystal 312 472 3627
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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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    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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    Santillanes, Crystal 312 472 3627
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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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    Thakkar, Priya 312 695 2573
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    A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of RO6867461 in Patients with Diabetic Macular Edema (RHINE)

    The purpose of this study is to compare the effects, good orbad, RO6867461 has on DME in comparison to aflibercep…

    The purpose of this study is to compare the effects, good orbad, RO6867461 has on DME in comparison to aflibercept.  The study will also evaluate the safety andtolerability of RO6867461.  In thisstudy, study participants will get either RO6867461 or aflibercept.  Aflibercept (Eylea®) is approvedby the U.S. Food and Drug Administration (FDA) for the treatment of DME and isconsidered one of the current standard-of-care medications for this eyedisease.  RO6867461 is an experimentaldrug, which means the FDA have not approved RO6867461 for the treatment ofDME. 

    • Age >/= 18 years
    • Documented diagnosis of diabetes mellitus (Type 1 or Type 2), as defined by the American Diabetes Association or per WHO criteria and
      • Current regular use of insulin for the treatment of diabetes

    and/or

      • Current regular use of oral anti-hyperglycemic agents for the treatment of diabetes
    • HbA1c of 10% within 2 months prior to the Day 1 visit date
    • Visual Acuity between 20/40 to 20/320
    • Diabetic Macular Edema

    Gill, Manjot KGill, Manjot K
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    NCT03622593 STU00208483
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    Thakkar, Priya 312 695 2573
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