Ophthalmology Clinical Trials

Ophthalmology Clinical Trials (Updated 2/15/16)

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

None currently

NEURO-OPHTHALMOLOGY CLINICAL TRIALS – Ongoing Recruitment

None currently

OCULOPLASTICS CLINICAL TRIALS – Ongoing Recruitment

None currently

PEDIATRIC CLINICAL TRIALS – Ongoing Recruitment

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.     ATS18: Binocular Computer Activities for Treatment of Amblyopia
This is a 32 week study comparing iPad therapy with patching for the treatment of amblyopia.  Children between the ages of 13 and 17 with amblyopia in at least one eye are eligible as long as they have not had any amblyopia treatment other than glasses for two weeks, and are wearing a stable glasses prescription.
2.     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. 

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.

Diabetic Retinopathy Clinical Research Network (PI: Garg)

1.         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.

 

UPCOMING STUDIES – NOT YET RECRUITING

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

None currently

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).

 

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.

 

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.

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.