A Study of Experimental Stem Cell Injection for Central Retinal Vein Occlusion (vision loss due to decreased blood supply in eye)

Volunteer for research at UC Davis Eye Center

Central retinal vein occlusion (CRVO) is an eye condition often associated with permanent loss of vision. CRVO blocks the blood supply to the retina. The retina is the part of the eye that captures the images that the eye sees and transmits the information to the brain. This blockage can damage your retina causing vision loss. In this study, we aim to learn more about a new procedure that involves injecting your own (autologous) stem cells into the eye. This approach is investigational and we do not have a lot of information about it. However, this stem cell procedure was used in a smaller study of 9 patients with different eye diseases including 1 patient with CRVO. The study was conducted by the same team led by Dr. Susanna Park at UC Davis. The aim of the current larger study is to get more information about this new procedure for patients with vision loss from CRVO. All participants will be randomly assigned to 1 of 2 groups. Both groups will receive one stem cell injection in the study eye. You will not be told which group you are in until the end of the study. Group 1 will have a bone marrow aspiration and stem cell injection during Study Period 1 or at the beginning of the study. During Study Period 2 or around 6 months into the study, Group 1 will have a sham or fake aspiration and a sham or fake injection. Group 2 will have a sham or fake aspiration and a sham or fake injection during Study Period 1 or at the beginning of the study. During Study Period 2 or around 6 months into the study, Group 2 will have bone marrow aspiration and stem cell injection.

Biological study, Phase [1, 2]
Any, age 18 years or older

A Study of Age-Related Macular Degeneration (vision loss) and Reticular Pseudodrusen (yellow pattern in the vision part of eye)

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Age-related macular degeneration (AMD) is a disease that causes blurred vision. It blurs the sharp, central vision you need for “straightahead” activities such as reading, sewing, and driving. AMD affects the macula, the part of the eye that allows you to see fine detail. The macula is located in the center of the retina, the light-sensitive tissue at the back of the eye. The most common early sign that a person is at risk for AMD is tiny yellowish spots beneath the retina called drusen. Drusen can be seen by your doctor and on images of your eyes. Most people over the age of 60 have a few small drusen and these are considered normal aging changes. The development of large drusen indicates that you are at risk for developing vision loss from AMD even though your vision may still be nearly normal. Reticular pseudodrusen (RPD) is a yellowish pattern that can appear in the macular area. It has been associated with an increased risk of developing vision loss. The late stages of RPD are similar to late AMD. The study doctors want to find out what AMD looks like inside the eyes of patients with the disease (phenotype) compared to patients without AMD. This may help doctors one day identify which genes may cause the disease (genotype). Your phenotype consists of the observable, physical characteristics. Your genotype is the genetic trait or traits found within your DNA. The goal of this project is to better understand the natural history and characteristics of early AMD and RPD. Another goal is to determine the course of the progression to intermediate and/or advanced AMD in eyes with early AMD or RPD. In addition, the study will be evaluating the presence of any risk factors for disease progression in participants with RPD. The study will gather patient information to create a large database. The database will be used to document changes in the eye over time and classify the changes that predict progression to vision loss in AMD. Investigators hope to possibly apply these findings to discover potential treatments for AMD.

Other Study
Any, age 55 years or older

A Study of Experimental Medicines Aflibercept vs. Bevacizumab for Diabetic Macular Edema (swelling in the center of the eye)

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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. The macula or center part of the retina is used for sharp, straight-ahead vision. It is nourished by blood vessels that may become affected by diabetes. The blood vessels are weakened by become leaky. This causes the retina to become thickened or swollen. Swelling of the central part of the retina can lead to decreased vision diabetes and may become leaky. This causes the retina to become thickened or swollen. Swelling of the central part of the retina can lead to decreased vision. DME can be treated with repeated injections of drug into the eye to try to make the swelling of the retina go away. The drug is used to block or decrease a substance called vascular endothelia growth factor (it is an “anti-VEGF drug”). There are currently three different anti-VEGF drugs that are used as injections in eyes. However, only the following two, Avastin® and Eylea®, are being used in this study. Avastin is approved by the Food and Drug Administration (FDA) for the treatment of cancer. It is not approved for treating DME. It needs to be specially prepared for injecting into the eye. However, studies have shown that Avastin injections can be beneficial for DME. Therefore, many doctors have been injecting it into the eye to treat DME. Eylea is the other type of anti-VEGF drug being used in this study and was made for injection into the eye. It has been approved by the FDA for treatment of DME. A recent survey of eye doctors estimated that about 60% of the injections in the U.S. for DME are given with Avastin, about 25% of the injections are given with Eylea, and about 15% with a third anti-VEGF drug called Lucentis®.

Drug study, Phase 3
Any, age 18 years or older

A Study of Experimental Treatment With Micropulse for Diabetic Macular Edema (build-up of fluid in the eye)

This study will test the effect of using the subthreshold micropulse diode laser (SML).

Diabetic macular edema (DME) is the term used for swelling in the central part of the retina. The retina is the light-sensitive tissue lining the back of the eye and is responsible for sharp, straight-ahead vision. The retina is nourished by blood vessels. These blood vessels can become weakened by diabetes. This causes the retina to become thickened or swollen. Swelling of the central part of the retina can cause vision loss. Some common treatment strategies for vision loss due to diabetic macular edema are: - laser treatment - intra-ocular injections with medications such as corticosteroids - anti-vascular endothelial growth factor (anti-VEGF) The purpose of this study is to test the effect of early treatment using the subthreshold micropulse diode laser (SML). This is a laser treatment that delivers laser energy in a “chopped” fashion allowing the tissue being treated to cool between pulses. Previous studies have shown that early intervention with SML may significantly improve or stabilize vision loss.

Device study
Any, age 18 years or older

Post-Approval Study of the Implantable Miniature Telescope

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The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity >2 lines from pre-surgery baseline level). The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is >17% against the alternative that the percentage is <17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is <17%.

Device study
Any, age 65 years or older

Spectroscopic optical coherence tomography (OCT), to measure the oxygen saturation in retinal blood vessels

Can spectroscopic OCT improve the early diagnosis of diseases such as glaucoma,diabetic retinopathy, and age-related macular degeneration?

Patients with glaucoma are not aware that they have the disease, mainly because current screening methods detect cellular and axonal loss in the retina and optic nerve head after years of disease progression, often after significant and permanent vision loss. A period of metabolic stress, potentially reversible through treatments or interventions, is thought to precede neuronal death and vision loss in glaucoma, presenting a “window of opportunity” for appropriate treatments. Importantly, oxygen metabolism supports the energetic requirements of neuronal activity and active transport in the inner retina, which have been shown to be impaired in early glaucoma before structural changes occur. However, no current test can measure such metabolic dysfunction on an immediate time scale to adequately diagnose, monitor, or predict disease progression. The purpose of this research is to investigate a new noncontact optical method, called spectroscopic optical coherence tomography (OCT), to measure the oxygen saturation in retinal blood vessels. Spectroscopic OCT may enable the assessment of retinal vessel oxygenation which could improve the early diagnosis of diseases such as glaucoma, diabetic retinopathy, and age-related macular degeneration (AMD).

Other
Any, age 18-60 years

Study comparing vision restoration with collagen cross-linked donor cornea and standard donor cornea

Boston Keratoprosthesis surgery study (cornea transplant for patients not candidates for traditional corneal transplant)

The Boston Keratoprosthesis is used in patients who are not candidates for a traditional corneal transplant. This could be because they have had a previous failed corneal transplant or have high likelihood for transplant failure due to a large amount of blood vessels in the cornea. The Boston Keratoprosthesis is assembled using a donated cornea tissue. The donated tissue can thin out in certain patients. Studies have shown that cross-linked corneas are broken down more slowly than corneas that have not been cross-linked. In this study patient will either receive a cross-linked donor cornea before Boston Keratoprosthesis surgery or will receive a standard-of-care non-cross-linked donor cornea. Randomization is like flipping a coin – neither patient, nor physician will know which treatment was received. In either scenario, the donor cornea will be delivered to the surgeon by Tissue Bank International (TBI) at the time of the surgery. The cross-linking procedure has not yet been approved by the United States Food and Drug Administration (FDA) and is therefore considered experimental. The cornea contains a protein called collagen that normally provides stability to the cornea (like the steel beams within a tall building). In this study, we will attempt to form extra connections between the collagen strands to make the cornea tissue stronger before it is used for the Boston Keratoprosthesis implantation. The extra connections, called “cross-links,” are formed by treating the cornea tissue with a special Riboflavin (Vitamin B2) with dextran solution and then carefully exposing it to a measured amount of ultraviolet light. Our goal is to get an indication whether this cross-linking treatment may reduce the rate of cornea thinning or melting.

Drug study, Phase I/II
Any, age 18 to 100 years old