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Clinical Trials in Ophthalmology

Saving sight through advanced treatment approaches


 

​Studies which are currently taking place and are enrolling new participants:

Cornea/External Disease:

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.

Glaucoma:

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)

Neuro-ophthalmology:

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)

Oculoplastics:

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

Pediatrc Ophthalmolgy:

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.

Retina:

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 Sigh​t 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.

Vision Rehabilitation:

No enrolling studies at this time.

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​Studies which are currently taking place, but are not enrolling new participants at our location:
 

Glaucoma:

Cataract Surgery with iStent
Sponsor: Glaukos Corporation                             NCT#01841450
Faculty: Seibold (PI), Pantcheva, SooHoo
Post-approval study of the Glaukos iStent Trabecular Micro-bypass Stent System in conjunction with cataract surgery.

Bimatoprost Sustained-release Implant vs Placebo for POAG/OHTN (Artemis)
Sponsor: Allergan Inc.                                        NCT#: 02250651
Faculty: Kahook (PI), Pantcheva, Seibold, SooHoo
The Efficacy and Safety of Bimatoprost SR in Patients with Open-angle Glaucoma or Ocular Hypertension.

Retina:

Radiation and Choroidal Melanoma
Sponsor:
CUSOM/Department of Ophthalmology   NCT#: 01460810
Faculty: Oliver (PI)
A prospective pilot study of surgical radiation shielding with vitrectomy and silicone oil tamponade, for the prevention of radiation-induced ocular injury in the treatment of choroidal melanoma with radioactive Iodine-125 plaque brachytherapy.

Triamcinolone Acetonide Injectable for the Treatment of Non-infectious Uveitis with Macular Edema (PEACHTREE)
Sponsor: Clearside Biomedical, Inc.                     NCT#: 02595398
Faculty: Palestine (PI), Mathias, Siringo
Evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.

5-year follow-up of Ranibizamab vs laser for Retinopathy of Prematurity (ROP) study (Rainbow Extension)
Sponsor: Novartis                                              NCT#: 02640664
Faculty: Mathias (PI), Oliver, Siringo
To evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP).

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​Sponsored studies which were completed/closed at our location within the past five years:
 

Cornea/External Disease:

RU-101 Ophthalmic Solution in Patients With Severe Dry Eye
​Sponsor: R-Tech Ueno, Ltd.                                NCT#: 01843894
Faculty: Davidson (PI)
Placebo-controlled study of recombinant human serum albumin (rHSA) for treatment of severe dry eye.

Efficacy Evaluation of Systane Ultra in Patients Scheduled for Cataract Surgery
​Sponsor: Alcon Research  ​                            NCT#: 01199510
Faculty: Davidson (PI)
Evaluating the effectiveness of FID 112903 (SYSTANE ULTRA® Lubricating Drops) plus standard of care to standard of care alone, in subjects with a history of intermittent eye irritation or dryness related to environmental factors and scheduled for routine cataract surgery.

Glaucoma:

Glaucoma Eye Drop (LUNAR)
Sponsor: Bausch & Lomb Inc.   NCT#: 01749930
Faculty: Seibold (PI)
Comparison of safety and efficacy of latanoprostene bunoda ophthalmic solution with timolol maleate ophthalmic solution for open-angle glaucoma or ocular hypertension.

Glaucoma Eye Drop
Sponsor: Allergan Inc.   COMIRB#: 13-2240
Faculty: Kahook (PI)
Evaluation of Bimatoprost 0.01% and Bimatoprost 0.03% in patients with glaucoma or ocular hypertension.

Ranibizumab with Mitomycin C During Trabeculectomy (OCTOPUS)
Sponsor: Genentech/CUSOM   NCT#: 00661583
Faculty: Kahook (PI)
Occlusion Prevention for Trabeculectomy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery.

The Effect of Pilocarpine on 24-hour IOP and OPP
Sponsor: CUSOM/Department of Ophthalmology      NCT#: 02754570
Faculty: Seibold (PI), Kahook, Pantcheva, SooHoo
The aim of this study will be to determine the effects of pilocarpine as an adjunct medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and compare these effects to latanoprost alone.

Use of Intravitreal Aflibercept for Neovascular Glaucoma
Sponsor: CUSOM/Regeneron   NCT#: 01711879
Faculty: Kahook (PI)
This study will assess the use of intravitreal aflibercept injections in patients with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.

Eye Pressure Measurement Study
Sponsor: Sensimed AG   COMIRB#: 12-1078
Faculty: Seibold (PI)
Tolerability and Functionality of a Wireless 24 Hour Ocular Telemetry Sensor in African-American Glaucoma Patients.

Patient Acceptance of Sustained Glaucoma Treatment Strategies
Sponsor: Johns Hopkins University                          COMIRB#: 16-1428
Faculty: Kahook (PI)

Safety and tolerability of RO7058584 for 7 days for Patients with Primary Open Angle Glaucoma or Ocular Hypertension
Sponsor: Hoffmann-La Roche                               ​  NCT#03293992
Faculty: Khook (PI), Pantcheva, Seibold, SooHoo

The Diurnal and Nocturnal Effect of Simbrinza and Timolol on IOP/OPP
Sponsor: CUSOM/Alcon Research  NCT#: 02165631
Faculty: Kahook (PI)
The primary aim of this study will be to determine the effects of Simbrinza at multiple intervals throughout a 24-hour period. The secondary aim will be to compare these to those of timolol.

Glaucoma Treatment Adherence and Persistence
Sponsor: CUSOM/Merck Sharp & Dohme Corp.   NCT#: 01409421
Faculty: Kahook (PI)
An Assessment of the Impact of Motivational Interviewing Via Glaucoma Educator on Glaucoma Treatment Adherence and Persistence.

Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on IOP/OPP
Sponsor: CUSOM/Alcon Research   NCT#: 01779778
Faculty: Seibold (PI)
The purpose of this research study is to determine the diurnal and nocturnal effects of Travoprost with SofZia (Travatan Z) on intraocular pressure and ocular perfusion pressure.

Brinzolamide 1% and/or Brimonidine 0.2% in POAG/OHP
Sponsor: Alcon Research   NCT#: 01297517
Faculty: Pantcheva (PI)
Three Month Efficacy and Safety Study of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2%, all Dosed Three Times Daily in Patients with Open-Angle Glaucoma and/or Ocular Hypertension.

Oculoplastics:

Teprotumumab Treatment in Patients With Active Thyroid Eye Disease
Sponsor: RiverVision   NCT#: 01868977
Faculty: Hink (PI), Liao
Placebo-controlled study of an insulin-like growth factor-1 receptor (IGF-1R) antagonist antibody administered every 3 weeks by intravenous infusion in patients suffering from active thyroid eye disease.

Retina:

Study of Fovista with either Avastin or Eylea compared to Avastin or Eylea Monotherapy (OPH1004)
Sponsor: Ophthotech Corporation                             NCT#: 001940887
Faculty: Mandava (PI), Mathias, Olson, Oliver, Siringo
Evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis against a control of Lucentis alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Port delivery system for sustained delivery of ranibizumab for Neovascular Macular Degeneration (LADDER)
Sponsor: Genentech, Hoffmann-La Roche                  NCT#: 02510794
Faculty: Oliver (PI), Mandava, Mathias, Olson, Pecen
To evaluate the efficacy, safety and pharmacokinetics of three different formulations of ranibizumab delivered via implant compared with the standard of care.

Suprachoroidal Triamcinolone Acetonide for Non-Infectious Uveitis (AZALEA)
Sponsor: Clearside Biomedical                                  ​ NCT#: 03097315
Faculty: Palestine (PI), Pecen, Siringo

Open-label Lampalizumab for Geographic Atrophy (OMASPECT)
Sponsor: Hoffman-La Roche                                      NCT#: 02745119
Faculty: Siringo (PI), Mandava, Olson, Mathias, Pecen
Extension study of SPECTRI.

Ranibizamab vs Laser for Retinopathy of Prematurity (RAINBOW)
Sponsor: Novartis Pharmaceuticals                            NCT#: 02375971
Faculty: Oliver, Siringo
To determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).

Lampalizumab vs Sham for Geographic Atrophy (SPECTRI)
Sponsor: Hoffman-La Roche                                      NCT#: 02247531
Faculty: Oliver (PI)​, Olson, Siringo, Mathias
To evaluate the efficacy and safety of lampalizumab administered by intravitreal injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Study Assessing Double-masked Uveitis Treatment (SAKURA)
Sponsor: Santen Inc.                                             NCT#: 01358266
Faculty: Palestine (PI)
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution for the treatment of active, non-infectious uveitis.

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Participant Information:

We appreciate your interest in Clinical Research at the University of Colorado School of Medicine, Department of Ophthalmology. 

If you are interested in any of our currently Enrolling studies, please contact Mary Preston at 720-848-2035.   

All clinical research is reviewed by an Institutional Review Board. Colorado Multiple Institutional Review Board (COMIRB) is an excellent resource for information about participating in clinical trials. Please visit their web site: www.ucdenver.edu/research/comirb​  

 

Other Resources:

www.clinicaltrials.ucdenver.edu​
www.clinicaltrials.gov
www.wirb.com/Pages/ResearchSubjects.aspx
www.nih.gov/health-information/nih-clinical-research-trials-you

 

Contact Information

Clinical Research
Department of Ophthalmology
University of Colorado School of Medicine
1675 Aurora Court, Mail Stop F-731
Aurora, CO  80045

Phone: (720) 848-2035
Fax: (720) 848-4670

e-mail: mary.preston@ucdenver.edu

 

If you are experiencing a threat to life, limb or eyesight, call 911.

Medical Emergency: 720-848-2020 (related to our clinical studies)

After hours/weekends: 303-281-8079 (related to our clinical studies)