Clinical Trials

• SatraGo2 TED Clinical Trial Patients with Thyroid Eye Disease 

  We are conducting a clinical trial to evaluate the effects and safety of a product called satralizumab for patients with thyroid eye disease (TED), also known as Graves’ eye disease or Graves’ orbitopathy.
  
  TED is an autoimmune condition where the body mistakenly attacks healthy tissues surrounding the eyes. Symptoms can range from mild to severe including, pain, bulging of the eyes, and double vision. TED is seen in two different phases, an active phase, where the eyes, eyelids, and eye muscles become swollen, eyes become red and bulge, and fatty tissue behind the eyes get larger, and an inactive/chronic phase where symptoms remain stable, but the fatty tissue hardens, leaving scarred eye muscles.
  
  Current treatment for moderate-to-severe active TED include steroids, and/or TEPEZZA (teprotumumab, in the US only), but these treatments may not be effective for all patients, and can cause many adverse effects. The only current treatment option for inactive/chronic TED is surgery. The purpose of this study is to evaluate the safety and efficacy of satralizumab subcutaneous (under the skin) injections in patients with TED compared to sham control.

• Meerkat UME Clinical Trial Patients with Uveitic Macular Edema

  We are conducting a clinical trial to evaluate a product called RO7200220 for patients with uveitic macular edema (UME), a complication of acute or chronic uveitis.

   

  UME causes fluid to accumulate in the tissue around the retina. The retina is the part inside the back of the eye which senses light and allows you to see. Accumulated fluid causes damage to the layers of the retina and can cause vision loss. UME can impair performance of activities such as driving, reading, recognizing faces, and other fine details of daily living. In the advanced stage of the disease, UME can result in severe vision loss or blindness.

   

  Currently available therapies for the treatment of UME may improve vision over time but are associated with significant adverse effects. There is an unmet need for effective non‑steroidal therapies for UME. The purpose of this study is to evaluate the safety and efficacy of RO7200220 intravitreal injections in participants with UME compared to sham control.

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• Ascent Gene Therapy Clinical Trial Patients with Wet Macular Degeneration 

  We are conducting a clinical trial to evaluate a gene therapy product called RGX-314 for patients with choroidal neovascularization (CNV), a form of wet age-related macular degeneration (AMD). 

  CNV causes progressive damage to the macula, the central region of the retina (inside the eye), which is involved in the fine details associated with reading, driving, and recognizing faces. In the advanced stage of the disease, CNV results in severe central vision loss. This impairs performance of many activities of daily living.

  Currently available anti-VEGF agents approved for the treatment of CNV may improve vision over time but these therapies must be re-administered often to prevent the disease from worsening. There is a significant need for a long-acting therapeutic in patients with nAMD to reduce injection burden. The purpose of this study is to evaluate the safety and efficacy of a single RGX-314 subretinal injection in participants with nAMD compared to repeated intravitreal (ITV) injections.

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• Aqueous Humor Dynamics (AHD) Clinical Trial Patients with Glaucoma

  Study looking to understand variation in eye pressure and glaucoma drug response. Glaucoma is a group of diseases that can damage the eye’s optic nerve. It’s a leading cause of blindness in people over the age of 60. But blindness from glaucoma can often be prevented with early treatment. 

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• Archway / Portal Clinical Trial Extension Patients with Wet Macular Degeneration (closed for recruitment)

  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 (non-neovascular) and wet (neovascular). In the "wet" form of AMD, abnormal blood vessels grow in the back of the eye. Sometimes these vessels leak blood or fluid that causes blurred and distorted vision. This process is also known as choroidal neovascularization (CNV). For people affected by "wet" AMD, vision loss may be quick and severe. This study is for participants with "wet" AMD. The purpose of this study is to evaluate the effects of investigational drug in research participants with wet AMD, and how it is absorbed into the body, when administered in combination with other AMD drugs. An investigational drug is one which has not been approved by the U.S. Food and Drug Administration (FDA) but is available in research studies like this one.

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• Derby / Gale Clinical Trial Extension Patients with Dry Macular Degeneration (closed for recruitment)

  We are conducting a clinical trial to evaluate a drug called APL-2 for patients with geographic atrophy (GA), a form of dry age-related macular degeneration (AMD).

  GA causes progressive damage to the macula, the central region of the retina (inside the eye), which is involved in seeing the fine details associated with reading, driving and recognizing faces. In the advanced stage of the disease, GA results in severe central vision loss, which impairs performance of many activities of daily living.

  Currently, there is no approved treatment for GA. APL-2, the study drug, is a complement inhibitor. The purpose of this study is to compare the effects of APL-2 versus placebo injection in patients with GA.

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• Pagoda Clinical Trial Patients with Diabetic Macular Edema (closed for recruitment)

  The purpose of this study is to investigate the effects and safety of the Port Delivery System (PDS) in patients with Diabetic Macular Edema (DME).  The PDS is an investigational drug delivery technology that allows physicians to continuously treat the eye with medication rather than frequent intravitreal injections.

  Diabetic macular edema (DME) is the term used for swelling in the small central part of the retina used for sharp, straight ahead vision due to diabetes. The retina is a thin layer of tissue that lines the back of your eye. It is nourished by blood vessels that become affected by diabetes.
  
  All participants will receive either Ranibizumab injections or the investigational Port Delivery System with Ranibizumab. No one will receive a placebo.

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• Pavilion Clinical Trial Patients with Diabetic Retinopathy (closed for recruitment)

  The purpose of this study is to investigate the effects and safety of the Port Delivery System (PDS) in patients with Diabetic Retinopathy.  The PDS is an investigational drug delivery technology that allows physicians to continuously treat the eye with medication rather than frequent intravitreal injections.

  Nonproliferative Diabetic Retinopathy (NPDR) is a leading cause of vision loss in patients with diabetes. NPDR occurs when the blood vessels within the retina (a tissue t the back of the eye) start to leak or bleed causing vision to be blurred and distorted. The retina is located at the back of the eye and controls central vision.
  
  All participants will receive either Ranibizumab injections or the investigational Port Delivery System with Ranibizumab. No one will receive a placebo.