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A Phase 3b/4, Double-masked, randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab Protocol Number: HZNP-TEP-402
Patients are “randomized” (assigned by chance) to receive one of the following study treatment lengths: • 4 infusions of TEPEZZA (teprotumumab) (Cohort [Group] 1), followed by either 4 infusions of TEPEZZA or 4 infusions of placebo (Placebo looks like the study drug, but does not inclu... Protocol #: 21-3831 |
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Tivanisiran for Dry Eye in Subjects with Sjogren's Syndrome
The purpose of this study is to compare the safety and effectiveness of tivanisiran sodium ophthalmic solution (eye drops) to placebo for treating signs and symptoms of DED in participants with a documented diagnosis of dry eye associated with Sjögren’s Syndrome. ... Protocol #: 21-2624 |
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Zoster Eye Disease Study (ZEDS):
A multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment
This study is looking to see if treatment with 12 months of daily valacyclovir medication reduces the development of certain types of new or worsening eye disease; specifically, infection on the surface of the front of the eye (cornea), inflammation of the cornea, or inflammation inside th... Protocol #: 17-0585 |
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A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long-Term Safety, Tolerability, Pharmocokinetics and Effects of ALK-001 on the Progression of Stargardt Disease
The TEASE studies (Tolerability and Effects of ALK-001 in Stargardt Disease) are a series of clinical trials evaluating an investigational drug called ALK-001 in people who have Stargardt Disease. There are no FDA-approved treatments to slow the progression of Stargardt Disease. Research s... Protocol #: 19-1103 |
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AMD Ryan Initiative Study (ARIS) - Longitudinal Study of Early AMD and Reticular Pseudodrusen
The goal of this project is to better understand the natural history and characteristics of early AMD. Another goal is to determine the course of the progression to intermediate and/or advanced AMD in eyes with early AMD and a certain finding associated with early AMD (Reticular Pseudodrus... Protocol #: 18-0520 |
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A PROSPECTIVE FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF QR-1123 IN SUBJECTS WITH AUTOSOMAL DOMINANT RETINITIS PIGMENTOSA (adRP) DUE TO THE P23H MUTATION IN THE RHO GENE
Currently there is no approved treatment for Retinitis Pigmesntosa due to the P23H mutation. The study drug is designed to repair the problem that causes vision loss due to this mutation. ... Protocol #: 19-2294 |
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Usefulness and performance with the IrisVision head-mounted video low vision aid in young individuals with congenital or early onset visual impairment
The IrisVision is a headset that is used by individuals with impaired vision to help them see better. This study plans to learn more about how well the IrisVision works for the younger population. If you meet the following criteria, you may be screened to participate in this study: ? Age... Protocol #: 19-2383 |
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An Open-label, Phase 1/2 Trial of Gene Therapy 4D-125 in Males with X-linked Retinitis Pigmentosa (XLRP) Caused by Mutations in the RPGR Gene
This is a multicenter study with two parallel parts: an observational Natural History Cohort and an open-label, prospective interventional trial in males with non-syndromic XLRP due to mutations in RPGR. The target population is restricted to avoid confounding atypical presentation in fema... Protocol #: 20-0130 |
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A Phase 3, Randomized, Adaptive Dose-Selection, Multi-Regional, Double- Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects with Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
This is the second study in which NCX 470 is being given to humans. Based on the results of an earlier study in which 326 subjects with your condition received NCX 470 eye drops (0.021%, 0.042% or 0.065%), the first part of the current study will examine two different concentrations of NCX... Protocol #: 20-0637 |
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A Phase 2 trial of AU-011 via suprachoroidal administration with a dose escalation phase (open-label, ascending single and repeat dose) and a randomized, masked dose expansion phase designed to evaluate the safety and efficacy of AU-011 in subjects with primary indeterminate lesions and small choroidal melanoma
This study is being conducted on patients diagnosed with a type of eye cancer called choroidal melanoma or an indeterminate lesion (a growth in your eye that is suspected to be melanoma), also known as eye melanoma. People who have choroidal melanoma are usually treated with radiation ther... Protocol #: 20-1186 |
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Field Test of Glaucoma Outcomes Survey
The American Glaucoma Society is interested to learn how quality of life improves for patients after minimally invasive glaucoma surgery combined with cataract surgery. They have designed a questionnaire, the Glaucoma Outcomes Survey (GOS), to try to find out how reliable the GOS survey is... Protocol #: 20-2477 |
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A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA? in Treating Patients with Chronic (Inactive) Thyroid Eye Disease
This research trial will compare TEPEZZA to a placebo (a “dummy” treatment). The trial drug TEPEZZA contains an active ingredient that is an inhibitor (slows down) of the “insulin-like growth factor 1” or IGF-1 receptor. The placebo looks just like the investigational drug but does not inc... Protocol #: 20-2835 |
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A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects
Patients diagnosed with stage 2 (persistent epithelial defect) or stage 3 (corneal ulcer) Neurotrophic Keratitis (NK) will take part in this study. Neurotrophic Keratitis (also called neurotrophic keratopathy) is a rare disease of the cornea that occurs when the nerves to the cornea do not... Protocol #: 21-3923 |
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A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)
Protocol #: 21-4929 Location: Outpatient CTRC, University of Colorado Hospital |