Ophthalmology Clinical Trials

Ophthalmology Clinical Trials (Updated 6/24/16)

Contact Eliza Dubose 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

Dry Eye / Reliability and Validity of the Dry Eye Symptom Severity Score (PI: Davis)

108 patients with dry eye and 50 control subjects are needed.  Patients will be asked to complete two symptom questionnaires, the Dry Eye Symptom Severity Score (DESSS) and the Ocular Surface Disease Index (OSDI), and participate in an exam of the cornea.  There will be a two week follow-up, at which point the DESSS will be completed for repeat reliability.

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).

 

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: Couser)

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: Gertsch)

  1. 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. 2.      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 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 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

 

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).

 

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

None currently

STUDIES IN PROGRESS (NO LONGER ENROLLING):

Diabetic Retinopathy Clinical Research Network (PI: Garg)

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.