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A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of RGX-314 Following Subretinal Administration in Participants with Neovascular Age-related Macular Degeneration and Fellow Eye Treatment Substudy
Rochester, Minn.
The purpose of this study is to evaluate the long-term safety and efficacy of RGX-314.
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A Randomized, Controlled, Partially Masked, Phase 3b Study To Assess The Injection Burden, Efficacy, Safety, And Long-Term Preservation Of Visual Acuity Of Surabgene Lomparvovec (ABBV-RGX-314) In A Real-World Context In Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Rochester, Minn.
Neovascular age-related macular degeneration (nAMD), also known as "wet" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD).
Surabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide.
Participants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study To Evaluate The Efficacy And Safety Of RGX-314 Gene Therapy In Participants With NAMD
Rochester, Minn.
The purpose of this study is to investigate the effectiveness and safety of two doses of RGX-314 administered as a single subretinal injection in the study eye of patients with nAMD, and to evaluate mean change from baseline in best-corrected visual acuity (BCVA) of RGX-314 relative to aflibercept at Week 54.
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Prevalence and Risk Factors for Pentosan Polysulfate Maculopathy: A Population-Based Analysis (PPS)
Rochester, Minn.
The purpose of this study is to to address the current lack of a true prevalent diagnosis of interstitial cystitis and perform outreach to prospectively screen patients with multimodal retinal imaging including fundus examination, fundus autofluorescence, spectral domain optical coherence tomography, and near infrared reflectance imaging by utilizing the Rochester Epidemiology Project (REP). Additionally, this study aims to provide additional insights into the risk of PPS maculopathy, investigate additional risk factors for PPS maculopathy development, and inform development of evidence-based screening guidelines.
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Vitreous Cavity Bacterial Contamination and Vitreous Fluidics after Vitreoretinal Surgery
Rochester, Minn.
The objective of this study is to evaluate and determine factors such as surgical technique, length of surgery, and surgical instrumentation associated with bacterial contamination of vitreous fluid following vitreoretinal surgery.
Closed for Enrollment
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A Phase 2, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study To Assess The Safety, Tolerability, And Evidence Of Activity Of A Repeat Intravitreal Injection Of UBX1325 In Patients With Neovascular Age-Related Macular Degeneration
Rochester, Minn.
A Phase 2, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Safety, Tolerability, and Evidence of Activity of a Repeat Intravitreal Injection of UBX1325 in Patients with Neovascular Age-Related Macular Degeneration
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