Contact Eliza Dubose at (919) 537-3674, Megha Karmalkar at (919) 843-0087, 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

None currently

Neuro-Ophthalmology Clinical Trials – Ongoing Recruitment

None currently

Oculoplastics Clinical Trials – Ongoing Recruitment

None currently

Pediatric Clinical Trials – Ongoing Recruitment

Retinopathy of Prematurity / Hand-Held Spectral Domain Optical Coherence Tomography Imaging of Infant Eyes (PI: Cabrera)

In this study, we are recruiting primarily premature infants to image the retina and optic nerve in order to better understand normal ocular development in this population as well as abnormal development (particularly in retinopathy of prematurity). The study is expected to last approximately 2 years.

Retina Clinical Trials - Ongoing Recruitment

Diabetic Macular Edema / Diabetic Retinopathy Clinical Research Network (PI: Garg)

1. DRCR S: Prompt Panretinal Photocoagulation versus Intravitreal Ranibizumab with Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

This is a 5 year study to determine if using Lucentis to treat Proliferative Diabetic Retinopathy (PDR) is no worse than the standard care PRP laser.

2. DRCR T: A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema

This is a 2 year study comparing Aflibercept (Eylea), Bevacizumab (Avastin), and Ranibizumab (Lucentis) for treatment of Diabetic Macular Edema.  Patients will be randomly assigned to receive one of the three drugs for the duration of the study.

Dry AMD  / Home Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeSeeHome Device / Notal Vision, LTD. (PI: Houghton)

This study is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in patients with Dry AMD (referred to as the ForeseeHome comprehensive solution) at high risk of progression to neovascular AMD improves detection of progression to choroidal neovascularization (CNV) when compared with standard care.  The study will last until December 2012 or until 1 year after the first wet AMD treatment is administered, whichever is longer.

Studies In Progress (no longer enrolling):

CMV Retinitis / National Institutes of Health (LSOCA Study) (PI: Meredith)

This is an observational study that investigates the effects of AIDS on the eye.  Study subject must have a documented history of AIDS.  This is a long term study that will currently last until at least 2013.

AMD Wet / AREDS2 Study / National Eye Institute (PI: Houghton)

This study is to evaluate the effect of formulated vitamins in high supplemental doses on the progression to advanced AMD.  Subjects must either have large drusen in both eyes or large drusen in one eye and advanced AMD in the fellow eye.  Participation will last for approximately 5 years.

Diabetic Macular Edema / Diabetic Retinopathy Clinical Research Network (PI: Garg)

1. Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema (Protocol I)
   This is a study that is comparing laser, triamcinolone, and ranibizumab (Lucentis®) for the treatment of DME.  Vision in the study eye must be between 20/32 and 20/320.  The study will last 5 years.
2. Intravitreal Ranibizumab for Vitreous Hemorrhage from PDR Study (Protocol N) This is a study to find out if an injection of Lucentis® through the vitreous (white part of the eye) can reduce the amount of bleeding in the vitreous enough to avoid surgery.  The study will last one year. Follow-up visits will be at 4, 8, 12, and 52 weeks.
3. DRCR M: Effect of Diabetes Education during Retinal Opthalmology Visits on Diabetes Control This study is to assess whether glycemic control (assessed with HbA1c measurement) in individuals with type 1 or type 2 diabetes can be improved with a point-of-care measurement of HbA1c in the ophthalmologist’s office combined with a personalized risk assessment for diabetic retinopathy and other complications of diabetes.