Ophthalmology Clinical Trials

Ophthalmology Clinical Trials (Updated 8/26/16)

Contact Eliza Dubose at (919) 260-1422, Kanika Bhansali at (984) 974-2057, or Sandy Barnhart, MPH at (919) 843-0076 for details regarding clinical trials in the UNC Department of Ophthalmology.

CORNEA CLINICAL TRIALS – Ongoing Recruitment

3D Spectral Domain OCT (RTVue) of Corneal Epithelial Thickness in Patients with Dry Eye, Glaucoma and Normal Controls (PI: Davis):   We will recruit patients to participate in the study pending IRB approval.  Subjects will have their eye imaged by a special camera that determines the corneal thickness and corneal epithelial (surface) layer thickness in subjects with dry eye, glaucoma, and normal eyes.  We are evaluating change in corneal epithelial thickness in these conditions.

 

Evaluation of Higher Order Aberrations in Patients with GVHD (PI: Davis):  Dry Eye is difficulty to manage and difficult to evaluate because symptoms and signs don’t often correlate.  We are developing new metrics to better understand dry eye status and treatment effectiveness.  Corneal topography, a test that images the corneal surface, may provide new metrics to evaluate dry eye.  The test is painless and similar to taking a photograph.  We will recruit 30 patients with dry eye and control subjects pending IRB approval: 10 with graft vs host disease, 10 with conventional dry eye, and 10 normal controls.

 

Validation of the E-Dems (PI: Chungfat): We will recruit subjects with dry eye disease to evaluate an electronic version of the UNC Dry Eye Management Scale (UNC DEMS), which is a simple one question that evaluates dry eye symptoms, effect on daily life, over a one-week time frame.  The validation work will ultimately convert our paper version that requires technician or physician administration to an electronically self-administered version on an iPad. We are recruiting 45 individuals: 30 with dry eye symptoms or diagnosed dry eye disease and 15 normal controls.

 

Metabolomic Analysis of Anterior Chamber Samples in Anterior Uveitis (PI: Chungfat)

This is a uveitis study performed in conjunction with the UNC Metabolomics core facility to analyze anterior chamber fluid from patients with anterior uveitis. We hope to recruit 5 patients with HLA-B27 uveitis and 5 patients with non-infectious idiopathic uveitis and obtain samples prior to starting treatment and once inflammation has stabilized on long-term therapy or off therapy completely. Five control patients will have fluid sampled at the time of cataract surgery for additional comparison.

GLAUCOMA CLINICAL TRIALS – Ongoing Recruitment

Assessing Ocular Hemodynamic Response to Surgical Intervention in Glaucoma (PI: Knight)

75 participants with varying degrees of open angle glaucoma (OAG) that meet clinical criteria for cataract or glaucoma surgery will be recruited from the glaucoma clinics at the UNC Kittner Eye Center, and twenty-five participants will be assigned to each of three study groups including, 1) cataract only, 2) cataract with iStent implantation, and 3) glaucoma surgery.  Participants will undergo assessment of 24 hour IOP and ocular perfusion pressure (OPP), retinal oxygen saturation (RSO2), and optic nerve blood flow (ONBF), within 10 days of their assigned surgical procedure and again 6-8 weeks post-operatively.  Total duration of follow-up: 3 months

 

HSC-MS-15-1053 - The AGS Second Aqueous Shunt Implant vs. TransScleral Cyclophotocoagulation Treatment Study (ASSISTS) (PI: Fleischman)

Patients who have undergone previous glaucoma surgery, and require additional surgery.  The study will last for five years (follow-up will be the same as your standard of care visits).

 

24-hr Intraocular Pressure Control with Brinzolamide 1%/Brimonidine 0.2% Ophthalmic Suspension vs. Vehicle (PI: Knight)

This is a glaucoma study that will be studying the overnight impact of a new glaucoma drug.  The study will last for 3 months, and will include 2 separate 24 hour visits at an overnight facility (one prior to starting treatment, and another one at the end of treatment).

 

NEIGHBORHOOD Consortium for POAG Genetics (PI: Budenz): We are looking for 50 patients  with Glaucoma (NTG or POAG), and 50 “Healthy” volunteers to provide 2 vials of blood and answer some basic medical history questions.  All subjects must be Caucasian and over 35 years of age.

 

Identifying the Genetic Basis of Glaucoma (PI: Fleischman): This study is looking for 500 Primary Open Angle Glaucoma patients of any race, gender, or ethnicity.  Subjects will need to obtain bloodwork or a saliva sample for a multi-center genetics study.

 

Retinal and Choroidal Blood Flow Imaging with Spectral Domain Optical Coherence Tomography (SDOCT) (PI: Mwanza): We are looking for 28subjects total, 14 with early or severe open-angle glaucoma and 14 “Healthy” volunteers to have the following imaging: Bioptigen, Cirrus OCT, and Oximetry. 

 

NEURO-OPHTHALMOLOGY CLINICAL TRIALS – Ongoing Recruitment

None currently

 

OCULOPLASTICS CLINICAL TRIALS – Ongoing Recruitment

None currently

PEDIATRIC CLINICAL TRIALS – Ongoing Recruitment

Retinopathy of Prematurity/ Novartis RAINBOW Study (PI: Ulrich)

Infants with a diagnosis of Retinopathy of Prematurity will be identified in the NICU and randomized to either laser or ranibizumab for treatment.  Participants will be followed for approximately 6 months.

 

Idiopathic Bilateral Cataracts/ Retrophin CTX Study (PI: Grace)

This is a study looking at the relationship between idiopathic bilateral cataracts and the diagnosis of CTX.  Patients will be identified via chart review (or referral), and will have some labs done to test for the presence of CTX.  Study consists of one visit.

Pediatric Eye Disease Investigator Group (PEDIG) (PI: Grace)

  1.  SAS1: A Prospective Observational Study of Adult Strabismus (SAS1)

This is a 1-2 year observational study examining the various treatment options for adult strabismus.  Treatment will be chosen by the study doctor with visits at 10 weeks and 1 year following enrollment.  If the doctor changes you to a new treatment, you will again be seen at 10 weeks and 1 year following the change. 

  1.  PON1: Pediatric Optic Neuritis Prospective Outcomes Study

This is an observational study for patients with a new diagnosis of Pediatric Optic Neuritis.  Study will last for 2 years, and follow-up will be the same as your standard of care.

RETINA CLINICAL TRIALS - Ongoing Recruitment

Dry Age-Related Geographic Atrophy/Genentech Proxima A (PI: Houghton)

This study is following the natural history of Advanced Dry AMD (Geographic Atrophy). This is a 4 year observational study with visits every 6 months.  Patients must have geographic atrophy in both eyes.  Vision must be 20/100 or better with no prior treatment for AMD other than AREDS vitamins.

 

Wet AMD/ Allergan CEDAR Study (PI: Houghton)

This is a two year study comparing ranibizumab (Lucentis) with a new study drug for treatment of wet AMD.  Patients will be followed monthly for two years, and must not have had any previous treatment for wet AMD.  Vision must be between 20/40 and 20/320.

 

Diabetic Retinopathy Clinical Research Network (PI: Garg)

DRCR W: Intravitreous Anti-VEGF Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk

This is a 4 year study looking at patients with Severe Non-Proliferative Diabetic Retinopathy (Severe NPDR).  Patients will be randomized to either study drug or sham injections to see if study drug injections help to prevent worsening of NPDR.  Participants will have best-corrected vision of 20/25 or better and not have any active diabetic macular edema, or any treatment for diabetic macular edema within the past year (including laser and injections).

 

UPCOMING STUDIES – NOT YET RECRUITING

 

Pediatric Eye Disease Investigator Group (PEDIG) (PI: Grace)

None currently

 

Neuro Imaging of Central Subfield in Glaucoma (PI: Fleischman)

This pilot study is looking at the cerebrospinal fluid in glaucoma patients.  13 patients total will be recruited (5 with Ocular Hypertension, 5 with Normal Tension Glaucoma, and 3 “Normal” patients without glaucoma).  Participants will have an MRI, and will receive compensation for this procedure.

STUDIES IN PROGRESS (NO LONGER ENROLLING):

Diabetic Retinopathy Clinical Research Network (PI: Garg)

DRCR V: Treatment for Central-Involved Diabetic Macular Edema in Eyes with         Very Good Visual Acuity

This is a 2 year study comparing laser, observation, and injections for treatment of Diabetic Macular Edema in patients with vision of 20/25 or better.  Patients will be randomly assigned to one of the three groups for the duration of the study.

 

DRCR AA: Peripheral DR Lesions on Ultrawide-field Fundus Images and Risk of Diabetic Retinopathy

Worsening Over Time

This is a 4 year study that will be obtaining ultrawide imaging on patients with diabetic retinopathy.  Patients will be followed annually for the study.

 

Correlation of UNC DEMS (Dry Eye Management Scale) and Anxiety and Depression (PI: Davis):

50 subjects are reporting their dry eye symptom score, the UNC Dry Eye Management Score, and anxiety and depression scores to evaluate the association between dry eye symptoms and anxiety and depression.  Recruitment closed.