Clinical Trials & Studies

National Eye Institute Biorepository for Retinal Diseases

Status: Active

PI: Vinit Mahajan, MD, PhD

Research Coordinators: Aarushi (Aarushi.kumar@stanford.edu)

For eligibility and more information, please see NCT01496625.

Background: To understand diseases of the retina and the eye, information is needed about people with and without such diseases. Researchers want to study these people and follow them over time. They also want to study body tissues and blood to understand the nature of eye disease. Studying genes, cells, and tissues may help them understand why some people get eye problems and others do not, or why some people respond to treatment while others do not. Researchers want to collect physical samples and personal data to develop a National Eye Institute database.

Objectives: To collect health information and blood and tissue samples from people with and without eye diseases, to be used in research studies.

Eligibility:
· Individuals of any age with different types of eye disease.
· Healthy volunteers with no history of eye disease.

Design:
· Participants may be recruited from National Eye Institute studies or may be referred from other sources.
· Participants will be screened with a physical exam and medical history. They will also have a full eye exam. Questions will be asked about family medical history, especially about eye disease.
· Blood samples will be collected. Other samples, such as saliva, tears, hair, stool, and urine, may be collected as needed. Adult participants may also provide a skin sample.
· Tissue or fluid from eye collected as part of eye care or treatment may also be added to the database.
· No treatment will be provided as part of this study.

A Phase 1b, Multicenter, Dose Escalation, Evaluation of Safety and Tolerability of ASP7317 for Geographic Atrophy Secondary to Age-related Macular Degeneration

Status: Active

PI: Theodore Leng, MD, FACS

Research Coordinator: Lorraine (lalmeda@stanford.edu)

For eligibility and more information, please see NCT03178149.

Background: The goal of this study is to evaluate the safety and tolerability of three increasing doses (dose escalation) of the experimental/investigational product, ASP7317, in people with dry AMD.

A Phase 1/2a, Open-Label Study to Evaluate the Safety and Tolerability of RPESC-derived RPE Transplantation as Therapy for Dry Age-related Macular Degeneration (AMD)

Status: Active

PI: Theodore Leng, MD, FACS

Research Coordinator: Lorraine (lalmeda@stanford.edu)

For eligibility and more information, please see NCT04627428.

Background: The primary objective of the study is to evaluate the safety and tolerability of RPESC-RPE-4W as a therapeutic intervention for dry age-related macular degeneration (AMD). RPESC-RPE-4W involves the transplantation of allogeneic retinal pigment epithelium (RPE) cells derived from RPESC (RPE stem cells) isolated from the RPE layer of human cadaveric eyes, specifically under the macula.

A Phase 2, Double-Masked, Randomised, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Orally Administered VX-01 in Diabetic Retinopathy of Non-Proliferative Type (NPDR) "See Clear Study

Status: Active

PI: Quan Nguyen, MD, MSc

Research Coordinator: Negin (nyavari@stanford.edu)

For eligibility and more information, please see NCT06770933.

Background: This is a multi-centre, double-masked, randomised, placebo-controlled, parallel group study that will evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of VX-01 as stand-alone treatment for NPDR (without CI-DME). The primary objective of the study is to evaluate the efficacy of daily oral doses of VX-01 versus placebo following 52 weeks of treatment. The investigational product (IP) in this study, VX-01, is being developed as a twice-daily (BID) oral treatment for diabetic retinopathy (DR).

Peak/Pinnacle- A Multicenter Platform Study on the Safety, Tolerability, Bioactivity, and Pharmacokinetics of Intravitreal Therapies in Retinal Vascular and Inflammatory Diseases.

Status: Active

PI: Quan Dong Nguyen

Research Coordinator: Negin (nyavari@stanford.edu)

Eligibility & More Information: NCT06996080

Background: KSI-101 is a novel, potent, biospecific biopharmaceutical that inhibits both interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF). Due to its biospecific inhibition of these two key cytokines responsible for inflammation and vascular hyperpermeability, KSI-101 has the potential to address an unmet medical need for effective non-steroidal therapies with an improved benefit-risk balance for the treatment of patients with macular edema secondary to inflammation (MESI).

A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects with Primary Non-metastatic Uveal Melanoma (OptimUM-10)

Status: Active

PI: Prithvi Mruthyunjaya, MD, MHS Pauline Funchain, MD

Research Coordinator: Monique (moniquenguyen92@stanford.edu)

For Eligibility & More Information: NCT07015190

Background: The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation. In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm). In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation. Subjects will then receive primary local therapy following neoadjuvant darovasertib. All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.

A Randomized Clinical Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss due to Radiation Retinopathy (Protocol AL)

Status: Active

PI: Prithvi Mruthyunjaya, MD, MHS

Research Coordinator: Monique (moniquenguyen92@stanford.edu)

For Eligibility & More Information: NCT05844982

Background: Radiation retinopathy (damage to the back of the eye) is a frequent complication after iodine-125 plaque brachytherapy (radiation)  for choroidal melanoma which is the most common tumor of the eye.  It is difficult to treat and results in profound loss of vision. A new drug may help in prevention of radiation retinopathy if given in an injection form to the eye, right when radiation exposure is going to begin. There are 2 experimental drugs that will be injected into the back of the eye at different time intervals during the study. First one is a steroid and it is thought to reduce the inflammation in the eye that radiation causes. Second is an experimental drug that may help with controlling inflammation in the eye and stabilizes any leakage from blood vessels.

Camizestrant (Ophthalmic Study)- A Multicentre, Open-Label Study Assessing Ophthalmic Safety of Camizestrant in ER+/HER2- Early Breast Cancer Patients Either Initiating Adjuvant Endocrine-Based Therapy (CAMBRIA-2) or Having Been Treated with Standard Adjuvant Endocrine-Based Therapy for At Least 2 Years (CAMBRIA-1).

PI: Prithvi Mruthyunjaya, MD, MHS

Research Coordinator: Monique (moniquenguyen92@stanford.edu)

For Eligibility & More Information: NCT06767462

Background: A collaboration with breast oncology team. Researchers would like to further understand if camizestrant affects vision and eye health in patients who are participating in CAMBRIA-1 and CAMBRIA-2 studies. We are doing this study to learn more about visual symptoms related to camizestrant, a drug which is being studied for the treatment of ER+/HER2- breast cancer.  In this ophthalmic study, researchers want to use highly specialized equipment and tests to further confirm that camizestrant does not cause physical effects on the eye. Some of the specific procedures described in the study have not been done yet in patients treated with camizestrant and this is why this is considered an experimental study

A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Belzupacap Sarotalocan (AU-011) with Suprachoroidal Administration in Subjects with Metastases to the Choroid (AURA 203)

PI: Prithvi Mruthyunjaya, MD, MHS

Research Coordinator: Monique (moniquenguyen92@stanford.edu)

For Eligibility & More Information: NCT06643884

Background: The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary carcinoma. The investigational treatment bel-sar (AU-011), is a combination product consisting of a biologic/drug conjugate (bel-sar), which is delivered into the SCS by a microinjector, and a laser photoactivation system (supplied by a contract manufacturer in accordance with Aura’s specification) that delivers 689 nm light to activate the drug once it is bound to the tumor cells. This is a Phase 2, multicenter, open-label, dose-ranging and treatment cycle escalation trial to assess the safety, tolerability, and initial treatment effect of 1 and 2 cycles of bel-sar treatment via suprachoroidal (SC) administration followed by laser light activation. The clinical trial will be conducted in subjects with metastases to the choroid from any primary carcinoma.

Hyperbaric Oxygen for Optic Neuropathies

PI: Jeffrey Goldberg, MD, PhD

Research Coordinators: Zac (glaucomatrials@stanford.edu)

For Eligibility & More Information:  NCT06128720

Background: The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.

Topical Insulin for Glaucoma (TING2)

PI: Jeffrey Goldberg, MD, PhD

Research Coordinators: Zac (glaucomatrials@stanford.edu)

For Eligibility & More Information:  NCT07619482

Background: This study evaluates the safety and preliminary efficacy of topical sterile human insulin eye drops (EYED-002) in patients with open-angle glaucoma. The study uses a phase 1/2 dose-escalation design followed by a masked, randomized, placebo-controlled phase. Insulin is formulated as preservative-free eye drops and delivered once daily. The primary objective is to determine the safety profile of topical insulin; secondary objectives assess effects on retinal structure, visual field, visual acuity, contrast sensitivity, and quality of life.

Visually Evoked Potential in glaucoma patients and controls

PI: Jeffrey Goldberg, MD, PhD

Research Coordinators: Zac (glaucomatrials@stanford.edu)

Background: The study is focused on finding new ways to detect and monitor glaucoma and its treatments.  We are looking for people who have been diagnosed with glaucoma or as glaucoma suspects, and for patients who have no glaucoma or other significant eye diseases for comparison. This test records the electrical activity of the brain in response to what you see with your eyes. 

Retinal Imaging in Degeneration and Regeneration

PI: Jeffrey Goldberg, MD, PhD

Research Coordinators: Zac (glaucomatrials@stanford.edu)

Background: The purpose of this study is to evaluate the retina of patients using a retinal metabolic analyzer to learn if more incipient changes in the retina can be detected using these devices. We hope that they can tell us about the retinas' health or degree of disease that may be caused by different eye conditions like glaucoma, optic nerve diseases or other retinal diseases. If this method of visualization is successful, we could have more sensitive monitoring of disease progression, and more accurate information for making decisions on treating eye conditions.

Electrical Stimulation for Vision Neuroenhancement in Glaucoma

PI: Jeffrey Goldberg, MD, PhD

Research Coordinators: Zac (glaucomatrials@stanford.edu)

For Eligibility & More Information:  NCT06685211

Background: The purpose of the study is to evaluate the efficacy of transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment of patients with glaucoma.

PENGUIN: An Exploratory, Pilot, Single-site Study to Evaluate the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation

PI: Wendy Liu, MD, PhD

Research Coordinators: Elena (glaucomatrials@stanford.edu)

For Eligibility & More Information: NCT07354477

Background: The purpose of this study it to evaluate QLS-111 at two concentrations to see if we can elicit any changes to the blood perfusion in the optic nerve head and retina after a week of dosing.

Retinal Biomarkers of Inflammation and Degeneration in Multiple Sclerosis

PI: Heather Moss, MD, PhD

Research Coordinator: Brenna (bajoe@stanford.edu)

Background: The purpose of this study is to evaluate novel non-invasive eye imaging biomarkers, with a focus on blood vessels, and neurons, as potential surrogates of brain inflammation and degeneration. The investigators hope to learn which quantitative retinal vessel metrics can be used to help characterize inflammation in patients with multiple sclerosis. This information is important as it will provide preliminary information to further investigate these metrics as biomarkers in future studies to determine retinal vessel markers as longitudinal markers of MS. This knowledge will eventually allow clinicians to easily and inexpensively characterize the inflammation in patients with MS to help preemptively treat patients and make better predictions on the prognosis of the disease.

Identifying Biomarkers for Visual Restoration Strategies in NF1-OPGs

PI: Jeffrey Goldberg, MD, PhD

Research Coordinator: Zac (zacwenn@stanford.edu)

Background: Through a combination of established and novel visual function testing methods, this study will define the functional, structural, metabolic and patient-reported components of NF1-OPG-induced vision loss. Findings are expected to inform the development of future therapies, validate existing models of the disease, and help identify new metrics for evaluating the efficacy of vision restoration treatments

Optic Disc Drusen and Eye Diseases

PI: Y. Joyce Liao, MD, PhD

Research Coordinator: Issa (ipalomat@stanford.edu)

Background: This is research study to better understand the  characteristics of a condition called optic disc drusen and other eye diseases like glaucoma, retinal vascular or degenerative diseases, or diseases causing pressure on the optic nerve (optic neuropathy) using new eye imaging techniques, questionnaires to learn about your vision, or change in the vision, and how it has impacted the patient's life, clinical assessments, and genetic analysis.

Optic Disc Drusen and Eye Diseases in Children

PI: Shannon Beres, MD

Research Coordinator: Lorraine (lalmeda@stanford.edu)

Background: This is a research study to better understand the characteristics of a condition called optic disc drusen in children. This study uses new eye imaging techniques, questionnaires to learn about your vision, or change in the vision, and how it has impacted the patient's life, clinical assessments, and genetic analysis

NF1- Optic Pathway Glioma Natural History Study

PI: Shannon Beres, MD

Research Coordinator: Jenika (jmaala@stanford.edu)

Background: The purpose of this study is to better understand the growth and treatment response of optic pathway gliomas. This study monitors visual acuity, visual fields, OCT measurements, MRI changes in children with NF1 who have optic pathway gliomas.

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

PI: Jennifer Rose-Nussbaumer, MD

Research Coordinator: Monique (moniquenguyen92@stanford.edu)

Eligibility & More Information: NCT05275972.

Background: In DETECT I, we will compare outcomes between two types of corneal transplant surgeries in eyes with more advanced endothelial disease. Both ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) replace diseased or damaged endothelial cells with healthy donor endothelial cells and it is not currently known which one is better. Healthy endothelial cells are important because they pump fluid out of the cornea to maintain the clarity of the cornea, which is essential for good vision. At the same time, we will determine whether adding a topical medication, ripasudil, protects the endothelial cells and improves outcomes.  In DETECT II, we will compare outcomes between two types of corneal surgeries: Descemet stripping only (DSO) and Descemet membrane endothelial keratoplasty (DMEK). In Descemet stripping only, diseased cells are removed from the cornea but there is no donor tissue. Remaining endothelial cells re-distribute to clear the central cornea over several weeks. It is thought that topical ripasudil may aid in this process.

Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery

PI: Edward Manche, MD

Research Coordinator: Theresa (theresae@stanford.edu); Ph: 650-498-7020

Eligibility & More Information: NCT07078799

Background: We are enrolling participants aged 22 or older for LASIK surgery in both eyes. We will perform wavefront-guided LASIK in one eye and ray tracing-guided LASIK in the fellow eye of each participant. We are trying to determine whether there are differences in efficacy between the two types of LASIK procedures.

We are comparing the outcomes of wavefront-guided LASIK (laser in-situ keratomileusis) and ray tracing-guided LASIK for nearsightedness with and without astigmatism.

Wavefront aberrometry (a non-contact laser measuring device) is an automated device that measures the refractive status of the eye. This data is then transferred to the laser system, which calculates a unique treatment to reduce or eliminate your nearsightedness with and without astigmatism (a non-spherical shape).

One eye will be treated with ray tracing-guided LASIK, and the other eye will be treated with wavefront-guided LASIK. Each participant will receive both wavefront-guided LASIK and ray-tracing guided LASIK. Both wavefront-guided LASIK and ray tracing-guided LASIK are FDA-approved procedures. Both procedures are being performed according to the FDA-approved labeling.

A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control

Status: Active

PI: Tawna Roberts, OD, PhD

Research Coordinator: Joellen (jleonen@stanford.edu)

For eligibility and more information, please see NCT07095894.

Background: The purpose of this study is to evaluate the effects of low-concentration atropine eye drops and/or glasses with special lenses on the progression of myopia.

A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles Plus Patching for Amblyopia in Children 3 to <13 Years Old (ATS22) 

Status: Active

PI: Tawna Roberts, OD, PhD

Research Coordinator: Joellen (jleonen@stanford.edu)

For eligibility and more information, please see NCT04378790.

Background: The primary objective of this study is to determine whether simultaneous treatment with spectacles and patching has an equivalent visual acuity outcome compared with sequential treatment, first with spectacles alone, followed by patching (if needed), for previously untreated amblyopia in children 3 to <13 years of age. 

A Randomized Trial of Virtual Reality Video Treatment for Amblyopia in Children 4 to 7 Years of Age

Status: Active

PI: Tawna Roberts, OD, PhD

Research Coordinator: Joellen (jleonen@stanford.edu)

For eligibility information, see: NCT06380517

Background: The purpose of this study is to find out if watching shows wearing the Luminopia headset (1 hour per day 6 days per week) improves amblyopic eye vision as well as treating amblyopia with patching (2 hours of per day 7 days per week). Luminopia presents images differently to each eye to try to restore the balance between the two eyes.

A Randomized Trial of Virtual Reality Video Treatment for Amblyopia in Children 8 to 12 Years of Age

Status: Active

PI: Tawna Roberts, OD, PhD

Research Coordinator: Joellen (jleonen@stanford.edu)

For eligibility information, see: NCT06524882.

Background: The purpose of this study is to find out if watching shows using the Luminopia headset or playing games using the Vivid Vision headset improves amblyopic eye vision better than wearing glasses alone. Both headsets present images differently to each eye to try to restore the balance between the two eyes.

Visual Cortical Functions in Children with or without Amblyopia (RPB)

PI: Tawna Roberts, OD, PhD

Research Coordinator:  Christabel Ameyaw Baah (ameyawbc@stanford.edu)

Background: The goal of the study is to understand motion perception, blur detection, and eye teaming in children and adults with a history of amblyopia and investigate how it compares to children and adults with normal, uncorrected vision. We hope also to gain insights into vision improvements when amblyopia is resolved due to eye patching, glasses, and other treatments.

An Evaluation of Quality of Vision and Quality of Life with LASIK, PRK and SMILE Surgery in Physicians

PI: Edward Manche, MD

Research Coordinator: Theresa (theresae@stanford.edu); Ph: 650-498-7020

Eligibility & More Information: NCT02576483

Background: The principal investigator is evaluating self-reported quality of vision and quality of life in physicians undergoing LASIK, SMILE and PRK surgery.

We are comparing the outcomes of wavefront-guided LASIK (laser in-situ keratomileusis) and ray tracing-guided LASIK for nearsightedness with and without astigmatism.

Wavefront aberrometry (a non-contact laser measuring device) is an automated device that measures the refractive status of the eye. This data is then transferred to the laser system, which calculates a unique treatment to reduce or eliminate your nearsightedness with and without astigmatism (a non-spherical shape).

One eye will be treated with ray tracing-guided LASIK, and the other eye will be treated with wavefront-guided LASIK. Each participant will receive both wavefront-guided LASIK and ray-tracing guided LASIK. Both wavefront-guided LASIK and ray tracing-guided LASIK are FDA-approved procedures. Both procedures are being performed according to the FDA-approved labeling.

A Prospective Randomized Comparison of SMILE Surgery to Ray Tracing-Guided LASIK Surgery

PI: Edward Manche, MD

Research Coordinator: Theresa (theresae@stanford.edu); Ph: 650-498-7020

Eligibility & More Information: NCT07721714

Background: Participants will undergo LASIK surgery in one eye using ray tracing guided technology in one eye and SMILE surgery in the other eye using wavefront guided technology. We are comparing outcomes between the two technologies as measured by self-reported quality of vision and quality of life outcomes using validated questionnaires before and after surgery. We will also be comparing outcomes between the two technologies including measurement of low contrast visual acuity, and best spectacle corrected visual acuity.

One eye will be treated with ray tracing-guided LASIK, and the other eye will be treated with wavefront-guided LASIK. Each participant will receive both wavefront-guided LASIK and ray-tracing guided LASIK. Both wavefront-guided LASIK and ray tracing-guided LASIK are FDA-approved procedures. Both procedures are being performed according to the FDA-approved labeling.

A Prospective Randomized Comparison of Wavefront-guided LASIK Surgery to Ray Tracing-Guided LASIK Surgery

PI: Edward Manche, MD

Research Coordinator: Theresa (theresae@stanford.edu); Ph: 650-498-7020

Eligibility & More Information: NCT07078799

Background: Participants will undergo LASIK surgery in one eye using ray tracing guided technology in one eye and LASIK surgery in the other eye using wavefront guided technology. We are comparing outcomes between the two technologies as measured by self-reported quality of vision and quality of life outcomes using validated questionnaires before and after surgery. We will also be comparing outcomes between the two technologies including measurement of low contrast visual acuity, and best spectacle corrected visual acuity.