Clinical Trials

• 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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• Gallego Clinical Trial Patients with Dry Macular Degeneration (closed for recruitment)

  We are conducting a clinical trial to evaluate a drug called FHTR2163 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 i sno approved treatment for GA. The purpose of this study is to evaluate the safety, tolerability, and efficacy of intravitreal (ITV) injections of FHTR2163 administered every 4 weeks or every 8 weeks in patients with GA compared to sham control.

• 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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• Lucerne / Avonelle-X 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 and recognizing faces.
  
  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 effectiveness of an investigational drug in research participants with wet AMD, and how it is absorbed into the body. 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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• 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. 

   

• Yosemite / Rhone-X Clinical Trial Extension Patients with Diabetic Macular Edema (closed for recruitment)

  The purpose of this research study is to investigate the effects and safety of RO6867461 administered intravitreally in patients with diabetic macular edema.

  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.

  Anti-VEGF drugs are injected into the eye to block a substance called vascular endothelial growth factor. These drugs have been used to treat DME because abnormal levels of VEGF are produced by retinas affected by diabetes. These abnormal levels of VEGF can cause leakage of fluid from the retinal blood vessels, which can cause swelling of the retina and potentially vision loss. There are several anti-VEGF drugs. All participants will receive either Lucentis® or the experimental drug, RO6867461. No one will receive a placebo.

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