Retina Clinical Trials

To learn more about clinical trials on treatments for eye disease please call or email the contact for the specific study below.

For a longer list of studies needing volunteers throughout the U-M Health System, please go to UMClinicalStudies.

On this page:

 

Studies that are Open and Enrolling

Title: Normative optical coherence tomography (OCT) database

IRB Number: HUM00072124
Status: Open/Enrolling

We are creating an image database of healthy human retinas by using optical coherence tomography (OCT), which is a non-invasive imaging technique. We are recruiting volunteers with healthy eyes to create a database of retinal images. We will take pictures of the back part of your eye(s) using a special technique called optical coherence tomography (OCT).  To take the pictures, you sit in front of the OCT instrument with your head in a chinrest while lights are shined into your eye(s).   We will also briefly review your medical records to ensure that you do not have any diseases that can affect your eyes and that you are not taking any medications that can affect your eyes.

Eligibility:

  • Must be 18 years of age or older

You may not participate if:

  • You have glaucoma, severe cataract, macular degeneration, or other eye diseases that impair vision
  • You have a neurologic or general medical condition that impairs vision such as uncontrolled high blood pressure, diabetes, stroke, multiple sclerosis, or HIV/AIDS
  • You have taken a medication that affects your eyes (like Plaquenil)
  • You have Parkinson’s disease or Alzheimer’s disease

Study Contact:

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Title: PeriOcular and INTravitreal corticosteroids for uveitic macular edema trial (POINT)

IRB Number: HUM00101130
Status: Open/Enrolling

The purpose of this study is to evaluate three of the most commonly used treatments for uveitic macular edema:  periocular triamcinolone, intravitreal triamcinolone, intravitreal dexamethasone implant. 

Eligibility:

  • 18 years of age and older
  • Non-infectious anterior, intermediate, posterior or panuveitis
  • Macular edema as assessed by study ophthalmologist

You may not participate if:

  • You have a history of infectious uveitis, scleritis, keratitis or endophthalmitis in either eye
  • You are pregnant or breastfeeding
  • You have a known allergy or hypersensitivity to any component of the study drugs
  • You have received placement of a Retisert implant in the past 3 years

Study contact:

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Title: Diabetic macular edema & mid-peripheral retina

IRB Number: HUM00109572
Status: Open/Enrolling

Diabetic retinopathy, a major complication of diabetes, is a visual impairment that impacts a person’s activities of daily living, social interaction, and emotional well-being. The purpose of our study is to better understand the effect of diabetic retinopathy on visual function in hopes of improving screening and treatment of the disease.
Eligibility:
Must be 18 years of age or older with one of the following conditions:

  • Do not have any diabetes mellitus
  • Do have diabetes mellitus, type 1 or type 2, with clinically evident diabetic retinopathy

Study Contact:

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Title: Comparison of perimetry techniques for identifying and monitoring early diabetic retinopathy

IRB Number: HUM00099155
Status: Open/Enrolling

Our study is interested in the type of screening and earlier detection for diabetic retinopathy in individuals at risk.  Diabetic retinopathy is a visual impairment that impacts a person’s activities of daily living, social interaction, emotional well-being and the participation in leisure activities and work. 
Must be 18 years of age or older with one of the following conditions:

  • Do not have any diabetes mellitus
  • Do have diabetes mellitus, type 1 or type 2, with clinically evident diabetic retinopathy
  • Do have mild to severe non-proliferative diabetic retinopathy

Study Contact:

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Title: Comprehensive ocular telemedicine assessment

IRB Number: HUM00072885
Status: Open/Enrolling

The purpose of this research is to identify methods that improve the usefulness, reliability, and validity of ophthalmic photographs that test for eye disease, vision, eye care questionnaire to help identify visual problems, increase eye care access in underserved communities, and provide a way to set up programs for eye disease screening.

Eligibility:

Must be 18 years of age or older with any of the following eye conditions:

  • Diabetic eye disease
  • Inflammatory Orbital Disease
  • Eyelid Tumors
  • Corneal Lesions
  • Ocular Surface tumors, scars, infections, inflammatory diseases, and swelling
  • Eye Movement Disorders
  • Glaucoma

Study Contact:

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Ongoing Studies

Title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration

IRB Number: HUM00118570

Age-related macular degeneration (AMD) is the leading cause of blindness in people over 50 years of age.  It is caused by the breakdown of the central portion of the retina (the nerve layer part of your eye that works like the film in a camera to pick up the picture) called the macula.  The macula is responsible for the fine central vision in the eye that is needed for driving a car, reading fine print, recognizing faces, etc. There are two types of macular degeneration: “dry” and “wet”.  In the "wet" form of AMD, abnormal blood vessels grow behind the retina towards the macula.  Sometimes these vessels leak blood or fluid that causes blurred or distorted vision. For subjects affected by “wet” AMD, vision loss may be quick and severe.  The purpose of this study is to evaluate the safety and efficacy of abicipar (2 mg), compared to 0.5 mg ranibizumab in treatment-naïve patients with “wet” AMD.

 

Title: Retinitis pigmentosa natural history study of patients with the P23H mutation of the rhodopsin gene

IRB Number: HUM00091441 

Retinitis pigmentosa (RP) is the name given to a group of hereditary eye disorders that affect the retina. The retina is the light-sensitive tissue that lines the back of the eye where the first stages of sight take place. There are special light sensing cells in the retina, called rods and cones. Rod cells are found outside of the central portion of the retina and help to transmit dim light and allow peripheral vision. Cones are located mainly in the center of the retina and help to distinguish colors and fine details. RP causes damage to the retinal rod and/or cone cells, causing vision loss. There are multiple genes that, when mutated, can cause RP, however, this research study will include only participants with autosomal dominant RP (ADRP) with the P23H gene mutation.

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Title: Treatment for central-involved diabetic macular edema in eyes with very good visual acuity (Protocol V)

IRB Number: HUM00081198

Diabetic Macular edema (DME) is the term used for swelling in the small central part of the retina. The retina is the light-sensitive tissue which lines the back of the eye. It is nourished by blood vessels that may become affected by diabetes. The blood vessels are weakened by diabetes and may become leaky. This causes the retina to become thickened or swollen. When the swelling is in the center of the macula, it can reduce vision. When vision is reduced from DME, an injection into the eye may be given of a drug that blocks a substance called Vascular Endothelial Growth Factor (“anti-VEGF drug”). Anti-VEGF drugs decrease the growth of new blood vessels and prevent leakage of fluid. Laser photocoagulation (“laser treatment”) is another method that is sometimes used to treat DME. Laser treatment is when a narrow beam of light passes into the eye through the pupil creating tiny scars in the retina. This helps to reduce the swelling. Until recently, laser treatment was the standard care for DME. The main purpose of the study is to find out which treatment approach, including observation, is best at keeping vision good when DME is present.

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Title: eSight quality of life and efficacy study

IRB Number: HUM00107420 

eSight Eyewear, developed by eSight Corporation, Toronto, is a portable, wearable, video device that may improve the functional performance of people with various low vision conditions. eSight Eyewear can be adjusted for various levels of magnification, contrast, and other attributes, as best suited for the individuals unique visual function. The aim of this study is to examine the impact of using eSight Eyewear on its user’s quality of life, independence, and general well-being.

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Title: Cryoanesthesia for intravitreal injections

IRB # - HUM00105826

The cryoanesthesia (CA) device is designed to provide anesthesia to a focal area on the surface of the eye immediately prior to intraocular injections. The purpose of the study is to collect preliminary data on the effectiveness of the cryoanesthesia (CA) device in minimizing the pain caused by intravitreal injections (IVT).

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Title: Treatment with Argus II retinal prosthesis system-post market study

IRB Number: HUM00081173

The Argus II Retinal Prosthesis System is used to treat advanced retinitis pigmentosa (RP) and is intended to provide electrical stimulation of the retina to induce visual perception in patients with bare to no light perception vision.
This study is a post-market approval study. This means that the device was approved for use as a humanitarian used device and more information was being collected regarding its safety and performance.

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Title: Genes in diabetic retinopathy project

IRB Number: HUM00060163

The diabetic retinopathy clinic research network (DRCR) is collecting DNA samples from people with diabetes and are storing them at a genetic repository. Enrollment is limited to patients who previously enrolled in a DRCR study.

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Title: Natural history observation and registry study of Macular Telangiectasia type 2

IRB #: HUM00047124

Macular Telangiectasia (MacTel) is a disorder of the blood vessels which supply the macula, the part of the retina (back of the eye) that is responsible for the central vision. The fovea, in the center of the macula, has no blood vessels at all because they would interfere with the central vision. MacTel refers to a condition of the blood vessels around the fovea which become dilated and incompetent, like varicose veins but on a much smaller scale. People do not usually go completely blind from this condition, but it commonly causes loss or distortion of the central vision.

At the present time there is no treatment for this disease. The purpose of this study is to identify persons with MacTel Type 2 and their affected family members to create a Registry.  This registry will be used to study eyes with MacTel Type 2 now and may be used in the future to identify potential patients for other studies.  Genetic samples of affected individuals and their families are collected to establish whether there is a genetic component of the disease. We also wish to keep in contact with these individuals with MacTel Type 2.

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Title: A Phase 2 multicenter randomized clinical trial of ciliary neurotrophic factor (CNTF) for macular telangiectasia type 2 (MacTel)

IRB Number: HUM00079094

Macular Telangiectasia (MacTel) is a degenerative condition of the macula that may cause progressive loss of vision. MacTel is a form of pathologically dilated blood vessels (telangiectasia) at the region of highest visual acuity, the yellow spot in the human eye (macula). Currently, there is no approved treatment for MacTel. This study is looking at whether and experimental implant containing Ciliary Neurotrophic Factor (CNTF) can be used to treat people with MacTel. CNTF is a small molecule that may help keep some nerve cells in your eye healthy. The implant, called NT-501, is a small capsule of cells that is placed inside the eye to allow the release of CNTF directly to the retina, the light sensitive part of the eye.

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Title: Prompt panretinal photocoagulation versus intravitreal Ranibizumab with deferred panretinal photocoagulation for proliferative diabetic retinopathy (Protocol S)

IRB Number: HUM00058229

This study looks at the effectiveness of Lucentis® compared to laser treatment for Proliferative Diabetic Retionpathy (PDR) and also evaluated if Lucentis® would have fewer side effects. PDR is a condition where new blood vessels and scar tissue form on the retina because of poor blood flow to the back part of the eye from diabetes. Ranibizumab (Lucentis®) is an FDA approved drug used to treat many different kinds of eye problems such as macular degeneration and retinal vein occlusion. Lucentis® has not been approved for PDR. Therefore, it is considered experimental for the treatment of PDR.

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Title: Comparative vitreous analysis / Analysis of vitreous composition

IRB Number: HUM00052760 and HUM00052709

This study is being done to analyze characteristics of the protein and cell content of the vitreous (gel-like substance within the eye) in order to further identify the molecular basis of different retinal (eye) conditions such as diabetic, retinopathy, diabetic macular edema, retinal vein occlusion, uveitis, and age-related macular degeneration.  The researchers hope better understanding of the protein chemistry of the eye in these conditions will lead to new and better treatments.

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Title: Mechanisms of visual function loss in proliferative diabetic retinopathy

IRB #: HUM00060596

The purpose of this study was to characterize deficits in retinal structure and function among patients with proliferative diabetic retinopathy and in subjects with healthy eyes (controls).   A number of tests were performed on participants, such as visual field measurements, dark adaptation, eye photographs, color vision assessment, and others. These tests posed minimal risk and none of the eye tests were invasive. A small amount of blood may have been obtained from participants to measure hemoglobin A1C levels. For control subjects, this study will require one visit to the Kellogg Eye Center. Patients with proliferative diabetic retinopathy did have up to 3 visits for this study. 

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Title: Diabetic retinal sensory neuropathy

IRB #: HUM00051733

The goals of this study were to develop improved means of detecting diabetic retinopathy (DR) in its earliest stages and to better understand how nerve damage from diabetes relates to eye damage from diabetes. This was a two year study that included eye exams and specialized eye tests (such as dark adaptation, visual fields, and electroretinography) at enrollment, one year, and two years of participation. The study provided new information about the earliest changes that diabetes exerts on the retina (back part of the eye) and on other nerves in the body. It may eventually lead to new ways of diagnosing, preventing, and treating diabetic retinopathy and neuropathy. 

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Title: ForeseeHome device for detection of macular abnormalities with macular telangiectasia Type 2 (MacTel)

IRB Number: HUM00099464

The goals of this project are to evaluate and describe the results of ForeseeHome test in terms of the location and depth of the scotomas (blind spots) discovered by the test and the location and the boundaries of the perceived visual disturbances or blind spots of the patient and to correlate those findings with the findings of OCT images of the retina. Enrollment is limited to patients who previously enrolled in NTMT-02 study.

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Title: Multicenter treatment trial (MUST Follow-up Study)

IRB Number: HUM00001490

This study is doing a five year follow-up for patients that participated in the MUST study. It was done to evaluate two different treatments for uveitis, a corticosteroid implant and oral corticosteroids.

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Title: Vital imaging of retinal/optic nerve diseases

IRB #: HUM00039819

Researchers at the Kellogg Eye Center evaluated an eye camera that has been modified to detect fluorescent signals from the retina (back of the eye). These signals serve as a functional marker to tell us about the retina's health or degree of disease progression that may be caused by eye diseases. Studying these signals in diabetes complications of the eye, and if they can be used as an early predictor for diabetes.

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Title: A Multiple-Site, Phase 1/2, Safety and Efficacy Trial of a Recombinant Adeno-associated Virus Vector Expressing Retinoschisin (rAAV2tYF-CB-hRS1) in Patients with X-linked Retinoschisis

IRB Number: HUM00100501 

X-linked Retinoschisis (XLRS) is a genetic eye disease that affects the retina (the lining of the back of the eye that detects light) and can cause vision loss. The vision loss is caused by “splitting” (or schisis) of the retina. XLRS is caused by mutations (changes) in a gene called Retinoschisin (RS1). The RS1 gene makes a protein that is important for the health of the retina. The purpose of this research study is to test whether an investigational study drug, called rAAV2tYF-CB-hRS1, is safe to use in humans, as it has not been tested in humans before, and to see if it can improve vision. The study drug is designed to allow the cells in your retina to make a normal RS1 protein.

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Last Modified: Monday, 14-Nov-2016 15:52:34 EST