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
Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects with Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
Sponsor: Nicox Ophthalmics NCT#: 04445519
Faculty: Kahook (PI), Hauswirth
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)
Field test of Glaucoma Outcomes Survey
Sponsor: Verana Health COMIRB# 20-2477
Faculty: Seibold (PI)
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 as a tool for measuring patient quality of life after undergoing minimally invasive glaucoma surgery combined with cataract surgery.
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.
Contributions of Varicella Zoster Virus in Giant Cell
Arteritis
Sponsor: UC Denver COMIRB# 18-0244
Faculty: Nagel (PI),
Subramanian
This study plans to learn more about varicella zoster virus
(VZV) being a possible cause of giant cell arteritis (GCA). This study also
aims to develop a fast and non-invasive diagnostic test for GCA.
Pediatric 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.
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.
RAINBOW extension study: an extension study to
evaluate the long-term efficacy and safety of Ranibizumab compared with laser
therapy for the treatment of Infants Born prematurely with retinopathy of
prematurity
Sponsor: Novartis NCT#: 02640664
Faculty: Mathias
(PI), Oliver
5 year follow up of Ranibizamab vs laser for Retinopathy of
Prematurity (ROP) Rainbow study
AMD Ryan Initiative Study (ARIS)- Longitudinal Study of
Early AMD and Reticular PseudodrusenSponsor: National Eye
Institute COMIRB#
18-0520
Faculty: Mandava (PI)
The primary purpose of this study is to gather patient
information for a large database to better understand and classify the changes
that predict progression to vision loss in AMD.
Phase 2 Tolerability and Effects of ALK-001 on Stargardt
Disease (TEASE)
Sponsor: Alkeus
Pharmaceuticals NCT#: 02402660
Faculty: Mathias
(PI), Mandava, Pecen, Smith
A Phase 2 Multicenter, Double-Masked, Randomized, Placebo- Controlled Study to Investigate the Long Term Safety, Tolerability, Pharmacokinetics and Effects of ALK-001 on the Progression of Stargardt Disease
Sponsor: Regeneron
Pharmaceuticals NCT#: 04101721
Faculty: Oliver (PI),
Mathias
This study involves research and is conducted to determine
the safety and effectiveness of a study drug called aflibercept and compare its effects
with laser therapy.
Sponsor: ProQR
Therapeutics NCT#: 04123626
Faculty: Mathias (PI),
Pecen, Mandava
The purpose of this study is to find out if different dose
levels (amounts) of the study drug are safe. This study will also measure
whether the study drug improves vision.
Sponsor: 4D Molecular
Therapeutics NCT#: 04517149
Faculty: Mathias
(PI), Pecen, Mandava
This study will test an investigation drug known as 4D-125
in individuals affected with XLRP due to a mutation in the RPGR gene.
Pavilion- A Phase
III, multicenter, randomized study of the efficacy, safety and pharmacokinetics
of the port delivery system with ranibizumab in patients with diabetic
retinopathy (PAVILION)
Sponsor: F.
Hoffmann-La Roche NCT#: 04503551
Faculty: Oliver (PI),
Pecen
The purpose of this study is to evaluate the effects of
ranibizumab when it is delivered by the Port Delivery System with ranibizumab (PDS)
for non-proliferative Diabetic Retinopathy.
Sponsor: Iveric Bio NCT#: 04435366
Faculty: Pecen (PI),
Mandava, Oliver, Olson, Mathias, Smith, Huvard, Chen
The objectives of this study are to evaluate the
effectiveness and safety of Zimura intravitreous administration compared to
sham when administered in research participants with geographic atrophy (GA)
secondary to dry age-related macular degeneration (AMD).
Sponsor: Aura
Biosciences NCT#: 04417530
Faculty: Oliver (PI),
Mathias
The purpose of this research study is to test the safety and
efficacy of AU-011 at different doses and different number of doses of study
drug when it is injected into the suprachoroidal space with one or two laser light
applications and to find out what effects, if any, it has on research
participants with a choroidal melanoma tumor or indeterminate lesion.
IrisVision- Usefulness and performance with the IrisVision headmounted video low vision aid in young individuals with congenital or early onset visual impairment
Sponsor: Children’s Hospital Colorado, UC Denver COMIRB# 19-2383
Faculty: Engle (PI), Hanson, Lewerenz
The purpose of the study is to determine how useful the IrisVision low vision aid is to teenagers and young adults with congenital or early onset vision loss and how well subjects perform specific activities with the IrisVision. The IrisVision is a headset that is used by individuals with impaired vision to help them see better.
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.
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)
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.
COOG2: Collaborative Ocular Oncology Group
Sponsor: University of Miami COMIRB#:
16-1445
Faculty: Oliver (Site PI)
Uveal Melanoma Validation Study Number 2
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)
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.
5-year follow-up of Ranibizamab vs laser for Retinopathy of Prematurity (ROP)
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.
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)
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.
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.
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
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.
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)
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.
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.
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
www.clinicaltrials.ucdenver.edu
www.clinicaltrials.gov
www.wirb.com/Pages/ResearchSubjects.aspx
www.nih.gov/health-information/nih-clinical-research-trials-you
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)