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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

Eye Donor Program

The eye donor program is designed to contribute to our understanding of diseases of the eye. Patients will be asked permission to have their eyes donated for scientific evaluation at the time of the death of the patient. Donated eyes will be studied at the eye pathology lab of the …
The eye donor program is designed to contribute to our understanding of diseases of the eye. Patients will be asked permission to have their eyes donated for scientific evaluation at the time of the death of the patient. Donated eyes will be studied at the eye pathology lab of the department of ophthalmology. Laboratory findings will be correlated and compared to the clinical findings observed in the same patients prior to their death.
Principal InvestigatorBryar, PaulBryar, Paul
IRB number STU00017021
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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 prevent the condition from developing and to find potential treatment(s) but more work is needed. Special …

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.

Eligibility Criteria

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

2. Must be 18 years of age or older.

Principal InvestigatorFawzi, Amani AFawzi, Amani A
Location(s)
  • Map it 259 E. Erie St. Suite 1520
    Chicago, IL
IRB number STU00206885
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Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening

Evaluating Fenofibrate for prevention of DR worsening- Screening visits then 2 visits per year for 4 years.

Eligibility Criteria

Mild to Moderate NPDR

Vision 20/25 or better

No prior treatment for DME or DR

Principal InvestigatorLyon, ALyon, A
ClinicalTrials.gov IdentifierNCT04661358IRB number STU00214531
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COAST

Primary SLT provides better clinical outcomes, fewer side effects, obviation of the need for daily self-dosing, and is cost-effective compared to topical medications. The recent publication of the LiGHT (Laser in Glaucoma and Ocular Hypertension) trial1 is likely to drive an overdue paradigm shift from our current medications-…

Primary SLT provides better clinical outcomes, fewer side effects, obviation of the need for daily self-dosing, and is cost-effective compared to topical medications. The recent publication of the LiGHT (Laser in Glaucoma and Ocular Hypertension) trial1 is likely to drive an overdue paradigm shift from our current medications-first approach to an SLT-first practice pattern in the management of primary open-angle glaucoma (POAG).

The overall goal of the study is to identify the optimal application of SLT therapy to provide maximal medication-free survival in trial participants with mild-moderate POAG or high-risk OHT.

The optimal energy and repeat interval for SLT have not been established. The trabecular meshwork (TM) undergoes ongoing cumulative damage from both the underlying glaucoma process and from SLT.2-5 Low energy SLT may cause less TM damage and extend TM responsivity to subsequent SLT treatments, thus extending medication-free survival. Repeated annually to maintain TM cell health (rather than delaying repeat SLT until TM cells become dysfunctional and IOP rises) may further extend medication-free survival.

Eligibility Criteria

1. Age 18 or older and in good health

2. Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):

a. High-risk ocular hypertension (OHT): IOP > 21 mmHg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the neuroretinal rim, visible nerve fiber layer defects, or asymmetry of the vertical cup-to-disc ratio of >0.2 between eyes) [enrollment of trial participants with High-risk OHT will be capped at 25% of total enrollment]

b. Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation better than -6.0 dB with no points in the central 5° <15 dB (see figure on next page)

c. Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5° points <15 dB or mean deviation -12.0 dB or better with 1 central 5° points <15 dB (see figure on next page).

3. Each eye with BCVA 20/200 (UK 6/60) or better

Principal InvestigatorTanna, Angelo PTanna, Angelo P
ClinicalTrials.gov IdentifierNCT04967989IRB number STU00215448
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NAC Attack

This study is a multicenter, randomized, double-masked, parallel and placebo-controlled trial in patients with RP to evaluated the efficacy and safety of 1800 mg bid NAC.

Eligibility Criteria

General Inclusion Criteria

• Ability and willingness to provide informed consent

• Age ≥ 18 and ≤65 years at time of signing Informed Consent Form

• Ability and willingness to comply with the study protocol and to participate in all study visits and assessments in the investigator’s judgement

• For candidates of childbearing potential: willingness to use a method of contraception

• Agreement not to take supplements other than vitamin A

Ocular Inclusion Criteria

• Both eyes must exhibit the RP phenotype with evidence of loss of night vision, gradual constriction of visual fields, and maintenance of visual acuity;

In addition, an eye must meet the following criteria to be included in the study:

• Gradable EZ on a horizontal SD-OCT scan through the fovea center with width ≤ 8000 μm and ≥1500 μm and with well-defined truncation at both the nasal and temporal sides;

ENG Version: 2.0 Version Date (YYYY-MM-DD) 2023-07-13

NAC Attack Protocol Page 39 of 40

• BCVA ≥ ETDRS letter score of 61 (20/60, [6/18] Snellen equivalent);

• Sufficiently clear ocular media and adequate pupillary dilation to allow good quality images sufficient for analysis and grading by central reading center.

General Exclusion Criteria

• Active cancer within the past 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with Gleason score ≤ 6 and stable prostate specific antigen for > 12 months

• Renal failure requiring renal transplant, hemodialysis, peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis during the study

• History of thrombocytopenia not due to a reversible cause or other blood dyscrasia

• Uncontrolled blood pressure (defined as systolic > 180 and/or diastolic > 100 mmHg while at rest) at screening. If a patient's initial measurement exceeds these values, a second reading may be taken 30 or more minutes later. If the patient's blood pressure must be controlled by antihypertensive medication, the patient may become eligible if medication is taken continuously for at least 30 days.

• History of other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion that oral NAC may be contraindicated or that follow up may be jeopardized

• Cerebrovascular accident or myocardial infarction within 6 months of screening

• Patients taking slow-release formulations of nitrates

• Participation in an investigational study that involves treatment with any drug or device within 4 months of screening

• Use of any interventional treatment to the retina such as transcorneal electrical stimulation within 4 months of screening

• Three relatives already enrolled in study

• Pregnant or breast feeding females. Women of childbearing potential who have not had tubal ligation must have a urine pregnancy test at screening.

• Known history of allergy to NAC or any non-medicinal ingredients in the study medication including citric acid, aspartame, sodium bicarbonate, and lemon flavor

• Having taken NAC in any form in the past 4 months

• Phenylketonuria

• Fructose intolerance

• Histamine intolerance

• Glucose-galactose malabsorption

• Sucrase-isomaltase insufficiency

• Any major abnormal findings on blood chemistry, hematology, and renal function lab tests that in the opinion of the Site Investigator and/or the Study Chair makes the candidate not suitable to participate in the trial

• HIV or hepatitis B infection

Angina that requires administration of sustained delivery of nitrates Being on strict sodium restriction that is deemed by the patient’s general medical doctor to be incompatible with the added sodium intake from study medication.

Ocular Exclusion Criteria

• Evidence of cone-rod dystrophy or pattern dystrophy including focal areas of atrophy or pigmentary changes in the central macula

• Cystoid spaces involving the fovea substantially reducing vision

• Glaucoma or other optic nerve disease causing visual field loss or reduced visual acuity

• Intra ocular pressure >27 mm Hg from two measurements. If a patient's initial measurement exceeds 27 mm Hg, a second reading must be taken.

• Any retinal disease other than RP causing reduction in visual field or visual acuity

• Any prior macular laser photocoagulation

• Intraocular surgery within 3 months prior to screening

• High myopia with spherical equivalent refractive error > 8 diopters. If an eye has had cataract surgery or refractive surgery, a pre-operative refractive error spherical equivalent > 8 diopters is an exclusion

• Any concurrent ocular condition that might affect interpretation of results

• History of uveitis in either eye

Principal InvestigatorRahmani, SafaRahmani, Safa
ClinicalTrials.gov IdentifierNCT05537220IRB number STU00219197
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IMVT-1401-3201

Brief Summary:

To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.

Eligibility Criteria

Participants must meet all the following criteria to be eligible for inclusion in the study:

-Are ≥ 18 years of age at screening

-Have a clinical diagnosis of TED associated with onset of active TED within 12 months prior to screening active

- Moderate to severe TED.

-Are euthyroid with the baseline disease under control or have mild hypo- or

hyperthyroidism.

Principal InvestigatorCohen, LizaCohen, Liza
ClinicalTrials.gov IdentifierNCT05517421IRB number STU00219951
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RGN-NK-302

To compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)

Eligibility Criteria
  • Persistent Epithelial Defect (PED)
  • Stage 2 or 3 Neurotrophic Keratopathy
  • BCVA score of less than or equal to 75 letters
  • At least 18 years of age
Principal InvestigatorFeder, Robert SFeder, Robert S
Location(s)
  • Map it 259 E. Erie St. Lavin Pavillion, Suite 15 20
    Chicago, IL
ClinicalTrials.gov IdentifierNCT05555589IRB number STU00220018
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