Studies which are currently taking place and are enrolling new participants:
Zoster Eye Disease Study (ZEDS)
Sponsor: NIH/NEI, NYUSOM NCT#: 03134196
Faculty: Cohen (PI), Wise (Site-PI), Davidson, Taravella, Gelston
Long-term Suppressive Valacyclovir Treatment for Herpes Zoster Ophthalmicus
General Ophthalmology and Optometry:
Exploration of Pupil Dilation in Horner's Patients Taking Flomax
Sponsor: Denver Health & Hospital Authority, University of Colorado NCT#: 03615508
Faculty: Ifantides (PI), Cralley
This study is evaluating the pupil dilation of Horner's Patients who have ever taken an alpha blocker such as Tamsulosin. Patients will undergo eye dilation as would occur at a yearly eye examination, but their pupil dilation measurements will be recorded.
Effect of Topical Steroid Drops on Blood Glucose
Sponsor: CUSOM/Department of Ophthalmology COMIRB#: 12-0328
Faculty: Pantcheva (PI), Taravella, Davidson
Effects and comparison of commonly used regimen of Prednisolone acetate 1% ophthalmic drops on blood glucose levels in non-diabetic and diabetic subjects.
Genetic Studies of Glaucoma
Sponsor: Duke University COMIRB#: 16-0138
Faculty: Kahook (PI)
A Trial of Neuroprotection With ACTH in Acute Optic Neuritis (ACTHAR)
Sponsors: UC Denver, UPenn, Mallinckrodt NCT#: 01838174
Faculty: Bennett, Shindler (Co-PIs) Study Coordinator: Ruth Johnson 303-724-7885
Neuroprotection with ACTH for acute optic neuritis with onset of symptoms within 14 days of current episode.
Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Sponsor: Quark Pharmaceuticals NCT#: 02341560
Faculty: Bennett (PI) Study Coordinator: Ruth Johnson 303-724-7885
Assess safety and tolerability of investigational product QPI-1007 via intravitreal injections and determine effect on visual functioning in subjects with recent onset (within 14 days) of NAION.
Gene Therapy for LHON 11778 (REFLECT)
Sponsor: GenSight Biologics NCT#: 03293524
Faculty: Subramanian (PI), Mandava, Mathias, Pecen, Palestine
The goal of this clinical trial is to assess the safety and efficacy of GS010, a gene therapy, in improving the retina functional & structural outcomes in subjects with LHON due to the G11778A ND4 mitochondrial mutation when vision loss duration is present up to one year.
Surgical Idiopathic Intracranial Hypertension Treatment Trial (SIGHT)
Sponsor: Jaeb Center for Health Research, NEI NCT#: 03501966
Faculty: Subramanian (PI)
Study to Assess the Efficacy and Safety of Raxone in LHON Patients (LEROS)
Sponsor: Santhera Pharmaceuticals NCT#: 02774005
Faculty: Subramanian (PI), Bennett, Pelak
External Natural History Controlled, Open-Label Intervention Study to Assess the Efficacy and Safety of Long-Term Treatment With Raxone® in Leber's Hereditary Optic Neuropathy (LHON)
Tears and Eyelid Surgery Study
Sponsor: CUSOM/Department of Ophthalmology COMIRB#: 12-1356
Faculty: Hink (PI)
Changes in Tear Film Osmolarity After Eyelid Surgery.
Meibography before and after lid surgery
Sponsor: CUSOM/Department of Ophthalmology COMIRB#: 17-1673
Faculty: Hink (PI), Liao, Echalier, Neems
Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS)
Sponsor: University of Colorado, Denver NCT#: 01773278
Faculty: Elias (PI), Braverman
Study Contact: 720-777-5401
Patients with biochemically confirmed SLOS are being treated with cholesterol supplementation and antioxidant medication.
Cerebrotendinous Xanthomatosis (CTX) Prevalence Study
Sponsor: Retrophin Medical NCT#: 02638220
Faculty: McCourt (PI), Peoples
Study Contacts: 720-777-4470, 720-777-4708
This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts.
SPOT Vision Screening
Sponsor: Children's Hospital Colorado, Welch Allyn NCT#: 03479021
Study Contact: Kyle Phillips, 720-777-0524
The purpose of this protocol is to determine if the Welch-Allyn Spot Vision Screener (SPOT) is effective at detecting various risk factors for poor vision in developmentally delayed children.
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Diabetic Macular Edema (RHINE)
Sponsor: Hoffmann-La Roche NCT#: 03622593
Faculty: Oliver (PI)
Argus II Retinal Prosthesis for Retinitis Pigmentosa
Sponsor: Second Sight Medical Products NCT#: 01860092
Faculty: Mandava (PI), Oliver
Argus® II Retinal Prosthesis System Post-Approval Study
Visual Function after Macula-off Retinal Detachment
Sponsor: ONL Therapeutics COMIRB#: 14-1227
Faculty: Mandava (PI)
Clear II: Uveal Melanoma
Sponsor: CUSOM/Department of Ophthalmology COMIRB#: 18-1410
Faculty: Oliver (PI)
COOG2: Collaborative Ocular Oncology Group
Sponsor: University of Miami COMIRB#: 16-1445
Faculty: Oliver (Site PI)
Uveal Melanoma Validation Study Number 2
Retinal Imaging for Familial Adenomatous Polyposis and Congenital Hypertrophy
Sponsor: CUSOM/Department of Ophthalmology COMIRB#: 14-1227
Faculty: McCourt (PI)
Familial Adenomatous Polyposis and Congenital Hypertrophy of the Retinal Pigment Epithelium.
No enrolling studies at this time.