Filter Results
Clinical Studies
Results filtered:Study status:
Open
Closed for Enrollment
Open
-
A Randomized, Controlled, Masked, Multi-center Study Evaluating the Efficacy, Safety, and Tolerability of Two Doses of AGTC-501 Compared to an Untreated Control Group in Male Participants with X-linked
Retinitis Pigmentosa (VISTA)
Rochester, Minn.
The purpose of this study is to evaluate and compare 2 doses of AGTC-501 to an untreated control group. A single subretinal injection of AGTC-501 (300 μL containing either 2.6 × 1011 vg/mL [low dose] or 2.4 × 1012 vg/mL [high dose]) will be administered in subjects in 2 treatment groups (N=~42), while subjects in the untreated control group (N=~21) will be followed and evaluated up to Month 12, after which they will be eligible to receive treatment with the high dose of AGTC-501.
.
-
NAC Attack, A Phase III, Multicenter, Randomized, Parallel, Double Masked, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral N-Acetylcysteine in Patients With Retinitis Pigmentosa (NAC Attack)
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness and safety of oral N-acetylcysteine (NAC) in patients with retinitis pigmentosa (RP).
-
The GUARD Trial - Part 1: A Phase 3 Clinical Trial of Repeated Intravitreal Injections of ADX-2191 for Prevention of Proliferaivie Vitreoretinopathy (n/a)
Rochester, Minn.
The GUARD Trial is a multi-center adaptive Phase 3 clinical trial of repeated intravitreal injections of ADX-2191 for the prevention of proliferative vitreoretinopathy.
Closed for Enrollment
-
A Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease
Rochester, Minn.
The purpose of this study is to determine if emixustat hydrochloride (emixustat) reduces the rate of progression of macular atrophy (MA) compared to placebo in subjects with Stargardt disease (STGD).
-
A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA in Combination with an Intravitreal Anti-VEGF Agent in Subjects with Retinal Vein Occlusion (TOPAZ)
Rochester, Minn.
The purpose of this study is to demonstrate the safety and effectiveness of CLS-TA ("suprachoroidal CLS-TA") used in combination with an anti-VEGF agent ("intravitreal anti-VEGF agent") in subjects with retinal vein occlusion (RVO).
-
New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System
Rochester, Minn.
The purpose of this study is to assess the effectiveness of the use of the Argus II retinal prothesis system in a larger US population than was available previously, within pre-approval studies.
-
New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System
Rochester, Minn.
This post-approval study is being implemented to monitor the use of Argus II System in a larger US population than available within pre-approval studies. An attempt will be made to include all eligible and willing subjects implanted with Argus II System in the United States.
-
Utility of Visual Pattern Recognition Technology in Retinal Prosthesis Patients: the ARGUSII/ORCAM Device Study
Rochester, Minn.
The purpose of this study is to determine if wearable, text-to-speech (TTS) and visual pattern recognition (VPR) technology can be used to extend the capabilities of the Argus II to allow patients to read and recognize faces and objects. Using the prosthesis, patients can identify obstacles, handles, switches, eating utensils and demonstrate improved navigation when used in conjunction with other ambulation-assist tools. The FDA has approved the Argus II as a humanitarian device. Present-day wearable text-to-speech converters are also capable of object and face recognition. Such systems have been developed to assist with these tasks in patients with severe low-vision.
ORCAM is a commercially-available eyeglass-mounted visual pattern recognition system capable of converting photographs of text to speech. It is comprised of a camera, a small belt-worn computer, pattern recognition software and a small audio transducer. ORCAM can acquire the image of a sheet of paper and read the text to the user through a small speaker adjacent to the ear. In addition, ORCAM can be trained to recognize faces and speak the name of the individual to the user. ORCAM can also be used to recognize everyday products after being programmed.
.