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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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DRCR – Genetics

This study is part of the Diabetic Retinopathy Clinical Research Network and aims to understand the genetic factors influencing retinal diseases, especially diabetic retinopathy (DR) and diabetic macular edema (DME). Researchers will collect blood samples from at least 5,000 participants to analyze genetic variations that may contribute to disease …

This study is part of the Diabetic Retinopathy Clinical Research Network and aims to understand the genetic factors influencing retinal diseases, especially diabetic retinopathy (DR) and diabetic macular edema (DME). Researchers will collect blood samples from at least 5,000 participants to analyze genetic variations that may contribute to disease progression or response to treatment. The samples will be stored in a research biobank and made available for future studies. The study hopes to identify genetic markers that could predict disease risk, treatment effectiveness, or potential side effects. This information could help develop more personalized treatments for retinal diseases. Participants provide informed consent, and their data is kept confidential. While there may be no direct benefit to participants, the findings could improve care for future patients with retinal diseases.

Principal InvestigatorLyon, Alice T.Lyon, Alice T.
IRB number STU00077798
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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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Pavilion

This clinical study is testing the Port Delivery System (PDS) with ranibizumab, an implantable device designed to provide continuous treatment for diabetic retinopathy (DR). Instead of frequent eye injections, the PDS slowly releases medication over time and only needs refilling every 36 weeks. The study will follow approximately 160 patients …

This clinical study is testing the Port Delivery System (PDS) with ranibizumab, an implantable device designed to provide continuous treatment for diabetic retinopathy (DR). Instead of frequent eye injections, the PDS slowly releases medication over time and only needs refilling every 36 weeks. The study will follow approximately 160 patients with DR to compare the PDS’s effectiveness and safety against standard observation without treatment. Researchers aim to determine if the PDS helps prevent vision-threatening complications and reduces treatment burden. Participants will undergo eye exams, imaging, and health monitoring throughout the study. If successful, the PDS could offer a more convenient and effective way to manage DR while maintaining vision health.

Principal InvestigatorGill, Manjot KGill, Manjot K
Location(s)
  • Map it 259 E. Erie St. Lavin Pavillion, Suite 15 20
    Chicago, IL
ClinicalTrials.gov IdentifierNCT04503551IRB number STU00212657
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Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening

This clinical study is testing whether the drug fenofibrate can help prevent diabetic retinopathy (DR) from worsening in people with diabetes. DR is an eye disease caused by diabetes that can lead to vision loss. The study includes 560 participants with mild to moderate DR, but without severe swelling in …

This clinical study is testing whether the drug fenofibrate can help prevent diabetic retinopathy (DR) from worsening in people with diabetes. DR is an eye disease caused by diabetes that can lead to vision loss. The study includes 560 participants with mild to moderate DR, but without severe swelling in the eye, and will follow them for up to six years. Participants will be randomly assigned to take either fenofibrate or a placebo (a pill with no active drug). Researchers aim to see if fenofibrate slows the progression of DR, reducing the need for more invasive treatments like eye injections or laser therapy. The study also explores how doctors can safely prescribe fenofibrate and monitor its effects in collaboration with primary care providers. If successful, this research could provide a new, widely accessible way to protect the vision of people with diabetes.

Eligibility Criteria

Mild to Moderate NPDR

Vision 20/25 or better

No prior treatment for DME or DR

Principal InvestigatorLyon, Alice T.Lyon, Alice T.
ClinicalTrials.gov IdentifierNCT04661358IRB number STU00214531
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COAST

The COAST clinical study is investigating the best way to use selective laser trabeculoplasty (SLT) to treat high-risk ocular hypertension and mild-to-moderate open-angle glaucoma. The study will compare two SLT energy levels—standard and low—to see which is more effective and safer. It will also …

The COAST clinical study is investigating the best way to use selective laser trabeculoplasty (SLT) to treat high-risk ocular hypertension and mild-to-moderate open-angle glaucoma. The study will compare two SLT energy levels—standard and low—to see which is more effective and safer. It will also examine whether repeating SLT annually at low energy is better than performing it only when necessary. Participants will be randomly assigned to different treatment groups and followed for four years, with regular eye exams to track intraocular pressure (IOP) and disease progression. The study aims to identify the optimal SLT treatment strategy to reduce the need for glaucoma medications while maintaining effective eye pressure control. If successful, the results could improve treatment guidelines and reduce the burden of glaucoma management for patients.

Eligibility Criteria

1. 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).

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

Principal InvestigatorTanna, Angelo PTanna, Angelo P
Location(s)
  • Map it 259 E. Erie St. Lavin Pavillion, Suite 15 20
    Chicago, IL
ClinicalTrials.gov IdentifierNCT04967989IRB number STU00215448
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A Randomized, Partially Masked, Controlled, Phase 3, Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ASCENT)

This Phase 3 clinical study is evaluating RGX-314, a gene therapy designed to treat neovascular age-related macular degeneration (nAMD), a leading cause of vision loss. The study compares the safety and effectiveness of a single subretinal injection of RGX-314 to regular eye injections of aflibercept, a standard …

This Phase 3 clinical study is evaluating RGX-314, a gene therapy designed to treat neovascular age-related macular degeneration (nAMD), a leading cause of vision loss. The study compares the safety and effectiveness of a single subretinal injection of RGX-314 to regular eye injections of aflibercept, a standard treatment for nAMD. Approximately 660 participants will be enrolled globally, with some receiving RGX-314 and others receiving aflibercept for 54 weeks. After this period, control participants may switch to RGX-314 if they meet eligibility criteria. The study will assess vision improvement, the need for additional treatments, and overall safety. If successful, RGX-314 could offer a long-term treatment option, reducing the need for frequent eye injections.

Principal InvestigatorLyon, Alice T.Lyon, Alice T.
ClinicalTrials.gov IdentifierNCT04514653IRB number STU00217937
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NAC Attack

This Phase 3 clinical trial, called NAC Attack, is testing whether the antioxidant N-acetylcysteine (NAC) can slow vision loss in people with retinitis pigmentosa (RP), a genetic disease that causes progressive blindness. The study will enroll about 438 participants across multiple sites in the U.S., Canada, Mexico, and …

This Phase 3 clinical trial, called NAC Attack, is testing whether the antioxidant N-acetylcysteine (NAC) can slow vision loss in people with retinitis pigmentosa (RP), a genetic disease that causes progressive blindness. The study will enroll about 438 participants across multiple sites in the U.S., Canada, Mexico, and Europe. Participants will take either NAC tablets or a placebo for 45 months, with regular vision tests and eye scans to measure the treatment's effects. Researchers aim to determine whether NAC can help protect retinal cells and slow the progression of vision loss. The study also monitors potential side effects and the long-term safety of NAC. If successful, NAC could become the first treatment to slow vision decline in RP patients, benefiting those at risk of losing their sight.

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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DRCR-AO

This clinical study is testing a new way to manage neovascular age-related macular degeneration (nAMD), a leading cause of vision loss. Currently, patients receive eye injections at regular intervals, but it’s unclear how often they truly need them. The study compares two treatment methods: one where patients follow …

This clinical study is testing a new way to manage neovascular age-related macular degeneration (nAMD), a leading cause of vision loss. Currently, patients receive eye injections at regular intervals, but it’s unclear how often they truly need them. The study compares two treatment methods: one where patients follow a "Treat and Extend" schedule (gradually extending time between injections) and another where patients use a Home OCT device for daily eye scans, which may allow for more personalized treatment timing. Researchers will track vision changes, injection frequency, and overall treatment burden over two years. The study includes 600 participants across multiple sites, all receiving the anti-VEGF drug Faricimab. By testing these approaches, the study aims to determine if Home OCT monitoring leads to better vision outcomes or fewer injections. If successful, this could reduce treatment costs and burdens while maintaining or improving vision care for nAMD patients.

Principal InvestigatorMirza, Rukhsana GMirza, Rukhsana G
IRB number STU00221281
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DRCR-AL

This clinical research study is investigating ways to prevent vision loss caused by radiation treatment for eye cancer. Radiation retinopathy, a condition that can develop after treatment, can lead to severe vision impairment. The study compares two different eye treatments—Faricimab injections and Fluocinolone Acetonide implants—against a control group …

This clinical research study is investigating ways to prevent vision loss caused by radiation treatment for eye cancer. Radiation retinopathy, a condition that can develop after treatment, can lead to severe vision impairment. The study compares two different eye treatments—Faricimab injections and Fluocinolone Acetonide implants—against a control group that receives no preventive treatment. Researchers aim to determine whether these treatments can reduce or delay vision problems by preventing swelling and damage in the eye. The study will follow 600 participants for three years, tracking their vision health through regular checkups. Participants are randomly assigned to one of the three groups and will receive treatment according to their group’s protocol. The goal is to find an effective strategy to protect vision in patients undergoing radiation therapy for eye cancer.

Principal InvestigatorBowen, Randy ChristopherBowen, Randy Christopher
IRB number STU00221284
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