Clinical Studies Currently Recruiting Patients

• Age-Related Eye Disease Study 2 (AREDS2)


Purpose: 
• To study the effects of high supplemental doses of dietary xanthophylls (lutein and zeaxanthin)and omega-3 long-chain polyunsaturated fatty acids (LCPUFAs)(DHA and EPA)on the development of advanced AMD.
• To study the effects of these supplements on cataract and moderate vision loss.
• To study the effects of eliminating beta-carotene from the original AREDS formulation on the development and progression of AMD.
• To study the effects of reducing zinc in the original AREDS formulation on the development and progression of AMD.
• To contribute data for validation of the photographic AMD scales developed from the Age-Related Eye Disease Study.


Study Chairs: Emily Y. Chew, M.D., (301) 496-6583


• Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study, The


Purpose: 
• To compare and contrast normal eye growth, ocular component development, and refractive error development in Hispanic, African-American, and Asian schoolchildren with what happens in Caucasian children from the Orinda Longitudinal Study of Myopia.
• To investigate risk factors for the development of myopia.
• To conduct DNA-based studies on nearsighted children and their families.


Study Chairs: Karla Zadnik, OD, PhD, (614) 292-6603, zadnik.4@osu.edu


• Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)


Purpose: 
The purpose of the study is to evaluate the relative efficacy and safety of treatment of subfoveal, neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.


Study Chairs: Daniel F. Martin, MD
Stuart L. Fine, MD, (404) 778-4380, dan.martin@emory.edu


• Convergence Insufficiency Treatment Trial (CITT)


Purpose: 
• Are Home-based Pencil Push-up therapy, Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics or Office-based VT/Orthoptics more effective than placebo treatment, and are there differences between the three treatments in improving subject symptoms and signs?
• To evaluate whether improvements in outcome measures are still present after one year of observation.


Study Chairs: Mitchell Scheiman, OD, (215) 276-6057, mscheiman@pco.edu


• Evaluation of Vitrectomy for Diabetic Macular Edema Study


Purpose: 
• To provide information on the following outcomes in eyes with DME that undergo vitrectomy: visual acuity, retinal thickening, resolution of traction (if present), surgical complications.
• To identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial.
• To obtain data that can be used to plan a randomized trial.


Study Chairs: Neil M. Bressler, M.D., (410) 955-8342, nbressler@jhmi.edu


• Infant Aphakia Treatment Study (IATS)


Purpose: 
• The primary purpose is to determine whether infants with a unilateral congenital cataract are more likely to develop better vision following cataract extraction surgery if they undergo primary implantation of an intraocular lens or if they are treated primarily with a contact lens. In addition, the study will compare the occurrence of postoperative complications and the degree of parental stress between the two treatments.


Study Chairs: Scott Lambert, M.D. , (404) 778-5522, slamber@emory.edu


• Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy


Purpose: 
• To find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment.


Study Chairs: Alexander J. Brucker M. D., (215) 662-8675, ajbrucke@mail.med.upenn.edu Neil M. Bressler, M.D., (410) 955-8342, nbressler@jhmi.edu


• Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema


Purpose: 
• To find out which is a better treatment for diabetic macular edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone.


Study Chairs: Neil M. Bressler, M.D., (410) 955-8342, nbressler@jhmi.edu Michael J. Elman, MD, (410) 686-3000, elman@elmanretina.com


• Multi-Center, Randomized, Phase II Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide and Avastin® in Combination with Photodynamic Therapy in Participants with Neovascular Age Related Macular Degeneration (VERTACL)


Purpose: 
• VERTACL will investigate whether a triple therapy, Avastin®, half fluence verteporfin photodynamic therapy (PDT), and triamcinolone acetonide-preservative free (TAC- PF), results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD.


Study Chairs: Karl G. Csaky, MD, PhD, (919) 681-6099, karl.csaky@duke.edu Frederick Ferris, MD, (301) 496-6583, flf@nei.nih.gov


• Multicenter Uveitis Steroid Treatment (MUST) Trial


Purpose: 


To compare the efficacy of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis, or panuveitis.

To compare the effectiveness of patching combined with active vision therapy plus near activities versus patching combined with control vision therapy plus near activities for moderate amblyopia (20/40-20/100) in 7 to <13 year olds.

Primary Analysis

The primary outcome measure is the proportion of patients with visual acuity of 20/25 or better in the amblyopic eye at the 17-week masked exam. These patients will be considered treatment responders. The primary analysis will consist of a comparison between the 2 treatment groups of the proportion of treatment responders with adjustment for baseline visual acuity.

Secondary outcomes are stereoacuity at the 17-week masked exam, mean improvement in visual acuity at the 17-week masked exam, and rate of improvement of visual acuity.

• This study is a randomized clinical trial designed to evaluate Bangerter filters compared to 2 hours of daily patching as a primary treatment for moderate amblyopia (20/40 to 20/80) in children ages 3 to < 10 years.
• Secondary objectives of this study are (1) to determine the time course of visual improvement with Bangerter filter treatment, (2) to compare patient quality of life, measured by a modified Amblyopia Treatment Index, between patients treated with patching vs. Bangerter filters, (3) to determine whether blurring the sound eye visual acuity below amblyopic eye visual acuity predicts improvement in acuity, and (4) to determine whether changing fixation to the amblyopic eye is predictive of improvement in visual acuity.
• The primary outcome assessment is visual acuity at 24 weeks for both the amblyopic and sound eyes.
• The primary analytic approach for the amblyopic eye acuity will involve construction of a one-sided 95% confidence interval to assess non-inferiority based on a treatment group comparison of logMAR visual acuity scores adjusted for baseline visual acuity scores in an analysis of covariance (ANCOVA) model.

• To evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to <8 years with visual acuity of 20/32 to 20/50 in the amblyopic eye.

• To determine whether adding topical steriods to antiobiotic treatment improves the outcomes of bacterial corneal ulcers, especially visual acuity.

• To monitor trends over time, in the incidence of CMV retinitis and other ocular complications of AIDS
• To determine the effect of highly active anti-retroviral therapy (HAART)-induced immune status on the risk of developing CMV retinitis and other ocular complications of AIDS
• To determine the characteristics (clinical, virologic, hematologic, and biochemical) of a population at high risk for CMV retinitis and other ocular complications of AIDS
• To evaluate the effects of treatments for CMV retinitis and other ocular complications on visual function, quality of life, and survival.

• To evaluate whether immunosuppressive therapy for ocular inflammatory disease is associated with increased long-term risk of mortality and/or cancer.
• To evaluate outcomes of ocular inflammatory diseases.

• The study objective is to determine the course of changes in OCT measured macular thickness and visual acuity following a single session of focal photocoagulation for center-involved DME.
• The purpose is to determine the proportion of eyes that continue to improve at least 5 letters in visual acuity or at least 10% in central retinal thickness after a session of focal photocoagulation. This information is needed to determine whether the current modified ETDRS treatment protocol used in DRCRnet protocols is overly aggressive in the criteria used to determine whether retreatment is indicated at four month intervals.
• The study will explore whether any baseline factors can be identified that are predictive of the response.