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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:

No enrolling studies at this time.

Glaucoma:

Bimatoprost Sustained-release Implant vs Placebo for POAG/OHTN
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.

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.

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.

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.

Patient Acceptance of Sustained Glaucoma Treatment Strategies
Sponsor: CUSOM/Department of Ophthalmology   COMIRB#: 16-1428
Faculty: Kahook (PI)

Neuro-ophthalmology:

Acute Optic Neuritis
Sponsor: CUSOM/Department of Neurology                     
Faculty: Bennett (PI)                  Study Coordinator: Ruth Johnson 303-724-7885
Neuroprotection with ACTH for acute optic neuritis with onset of symptoms within 12 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.

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)

Retina:

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

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.

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.

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.

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).

T Cell Function in Herpes Zoster Uveitis (VZV)
Sponsor: CUSOM/Department of Ophthalmology   COMIRB#: 16-1886
Faculty: Palestine
We are conducting a study to assess the response of the immune system to the virus that causes Shingles. We hope to better understand how this virus affects the eye, allowing eye doctors to improve treatment for this disease.

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.

Vision Rehabilitation:

No enrolling studies at this time.

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

Retina:

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).

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

 
​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.

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.

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)
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
Sponsor: Ophthotech Corporation   NCT#: 001940887
Faculty: Mandava (PI), Olson, Oliver, Siringo, Mathias
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).

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.

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:  http://www.ucdenver.edu/academics/research/AboutUs/comirb/research-subjects/Pages/research-subjects.aspx

 

Other Resources:

http://clinicaltrials.gov/
http://www.wirb.com/Pages/ResearchSubjects.aspx
http://health.nih.gov/ 
http://www.ucdenver.edu/academics/colleges/medicalschool/research/Pages/ClinicalTrials.aspx
 

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

After hours/weekends: 303-281-8079