Clinical Trials in Ophthalmology

​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

Glaucoma:

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.

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.

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.

Retina:

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

ButterflEye - Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients with Retinopathy of Prematurity
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.

Aurora-  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 Rhodopsin Gene
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.

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
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. 

GATHER2- A phase 3 multicenter, randomized, double-masked, sham controlled clinical trial to assess the safety and efficacy of intravitreal administration of ZIMURA™ (complement C5 inhibitor) in patients with geographic atrophy secondary to dry age-related macular degeneration
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).

AU-011-202;  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
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.

Vision Rehabilitation:

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.