Growth and Retinopathy of Prematurity Registry Save

Date Added
April 26th, 2016
PRO Number
Pro00053408
Researcher
Edward Cheeseman
Keywords
Vision/ Eye
Summary

The purpose of the registry is to provide a mechanism to store clinical data to support future research about postnatal weight gain based risk prediction for severe ROP and secondarily severe ROP and ROP treatment rates. If validated, the predictive model would eventually replace current ROP screening guidelines in determining the necessity and timing of ROP examinations for premature infants.

Institution
MUSC
Recruitment Contact
Kinsey Shirer
843-792-2799
evanssa@musc.edu

New Enrollment Post-Approval Study of the Argus (R) II Retinal Proshesis System Save

Date Added
April 21st, 2016
PRO Number
Pro00043355
Researcher
Luciano Del priore
Keywords
Vision/ Eye
Summary

The Argus II Retinal Prosthesis System is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals with retinitis pigmentosa. This is a post-market study gathering safety data and evaluate measures of visiual function to ensure that the risks ad benefits of the device continue to be acceptable (post FDA approval). Data gathered during this study may aso contribute to improvements to the device.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Treatment with the Argus II Retinal Prosthesis System a Humanitarian Use Device. Save

Date Added
April 6th, 2016
PRO Number
Pro00043514
Researcher
Luciano Del priore
Keywords
Vision/ Eye
Summary

The Argus II Humanitarian Use Device is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

A PHASE II, MULTICENTER, RANDOMIZED, ACTIVE TREATMENT?CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF THE RANIBIZUMAB PORT DELIVERY SYSTEM FOR SUSTAINED DELIVERY OF RANIBIZUMAB IN PATIENTS WITH SUBFOVEAL NEOVASCULAR AGE-RELATED MACULAR DEGENERATION Save

Date Added
April 1st, 2016
PRO Number
Pro00043506
Researcher
W. lloyd Clark
Keywords
Vision/ Eye
Summary

Study GX28228 is a Phase II, multicenter, randomized, active treatment (monthly ITV injection)?controlled study to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered through the Implant using three ranibizumab formulation arms (10 mg/mL, 40 mg/mL, and 100 mg/mL) compared with the control arm (0.5-mg monthly ITV injections of 10-mg/mL formulation) in patients with subfoveal neovascular (wet) AMD. The study will also evaluate the safety of the RPDS combination product.

Institution
Palmetto
Recruitment Contact
Tiffany Swinford
803-404-5037
tswinford@palmettoretina.com

Amblyopia Treatment Study (ATS18) Study of Binocular Computer Activities for Treatment of Amblyopia Save

Date Added
March 15th, 2016
PRO Number
Pro00041906
Researcher
Edward Cheeseman
Keywords
Vision/ Eye
Summary

Ambylopia treatment study to compare the effectiveness of binocular game play versus patching in children ages 5 to < 17 years of age.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Cell Modeling of Human Retinal Degenerations: Insights using Patient-Specific Human Induced-Pluripotent Stem Cells (iPSCs) Save

Date Added
March 15th, 2016
PRO Number
Pro00023262
Researcher
Luciano Del priore
Keywords
Aging, Rehabilitation Studies, Vision/ Eye
Summary

The purpose of this study will be to collect a skin biopsy (skin tissue) or blood sample from each participating patient with retinal degeneration, such as Best?s disease or age-related macular degeneration (AMD), including geographic atrophy (GA). Each skin biopsy or blood sample will be taken to the laboratory of the investigators where skin epithelial cells called fibroblasts, will be induced to make ?pluripotent stem cells? or ?iPSCs?. These iPSCs will be differentiated into retina epithelial cells which will be tested for their ability to function as new retinal cells in animal models of retinal degeneration. Because these special cells are individualized or patient-specific, they will not be rejected by that individual patient, and thereby represent the first step in a potential future treatment for retinal disease. Cells will also be processed at the New York Stem Cell Foundation IPSC core facility using the procedure described above. The Medical University of South Carolina (MUSC) and New York Stem Cell Foundation (NYSCF) will enter into a material transfer agreement (MTA) initiated by the MUSC Foundation for Research Development. Once MTAs are initiated, samples will be coded at MUSC. Coded samples will be sent via dry ice to ensure full competency to the NYSCF. Samples will remain coded at MUSC and will not be released to the NYSCF. Fibroblasts will be reprogrammed using the method described above and sent back to MUSC (as iPS cells) for the research purposes of this study. Cells will only be identifiable to the NYSCF by disease, sex, and gender. Once cells are received by the NYSCF they receive a number bar code for further processing and are in no way traceable to the patient by the NYSCF. Reprogrammed cells will be stored at the NYSCF biorepository but only shared with the knowledge of MUSC. These samples will be used for the purposes of this study. Any other use will be evaluated by the investigators and the MUSC Foundation for Research Development and the appropriate action taken. Once samples are processed that will not be withdrawn from the biorepository. The NYSCF biorepository is a secure facility with only authorized personnel having access to the facility

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LAMPALIZUMAB ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION Save

Date Added
January 12th, 2016
PRO Number
Pro00039041
Researcher
Luciano Del priore
Keywords
Vision/ Eye
Summary

This study is to compare the effect of an investigational drug (Lampalizumab) in an injection to the eye every 4 to 6 weeks compared to a sham (false ) injection on the effects of Geographic Atrophy secondary to patients with Age Related Macular Degeneration. This study will last for 2 years. The study will involve blood draws and numerous ophthalmic exams.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Long Term Safety Follow-up for Subjects Previously Implanted with the the AcrySof® Cachet™ Phakic Lens in Clinical Studies C-02-23, C-02-40, C-03-21 and C-05-57 Save

Date Added
December 8th, 2015
PRO Number
Pro00014945
Researcher
Matthew Nutaitis
Keywords
Vision/ Eye
Summary

This study will gather long-term data to better understand the safety of the ACRYSOF® Cachet™ Phakic Lens.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Validation of the Pediatric Sensory Modality Assessment and Rehabilitation Technique (SMART) Save

Date Added
December 1st, 2015
PRO Number
Pro00048514
Researcher
Cynthia Dodds
Keywords
Brain, Children's Health, Hearing, Vision/ Eye
Summary

The purpose of this project is to study validity of a newly developed pediatric tool, the Pediatric Sensory Modality Assessment and Rehabilitation Techniques (SMART), which will measure cognitive awareness for children with severe brain damage. Thirty children, between the ages of 3-21 years, with physician-documented severe brain damage and considered medically stable are needed for this study. Recruitment flyers will be disseminated at iHope (school serving children with severe disabilities) in NY, NY, MUSC and the greater Charleston area community to recruit parents/legal guardians of children with severe brain damage. Once parental/legal guardian and physician consents are in place, participants will be evaluated using the Pediatric SMART 5 times within 10 days. The Pediatric SMART is made up of 5 domains that are olfactory, visual, auditory and vestibular, gustatory, and tactile. Test administration requires approximately 1 hour and can be completed in settings convenient for parents/legal guardians. The potential benefit to study participants is that the findings from the Pediatric SMART may identify sensory and motor strengths of participants. Knowledge of these strengths may enhance current rehabilitation and treatment plans, which may lead to functional improvements; although, this cannot be guaranteed. It is a goal of this study to evaluate Pediatric SMART validity. Once validity has been substantiated for the Pediatric SMART by means of further study, future children with severe brain injury, being evaluated with the Pediatric SMART, may have rehabilitation and treatments opportunities that are better informed, leading to greater improvement in functional and participatory outcomes.

Institution
MUSC
Recruitment Contact
Cynthia Dodds
843-792-5731
doddscb@musc.edu

Intacs Inserts-Prescription Inserts for Treatment of Patients with Keratoconus (HDE) Save

Date Added
November 17th, 2015
PRO Number
Pro00046816
Researcher
George Waring iv
Keywords
Vision/ Eye
Summary

Intacs® Corneal Implants is a FDA Humanitarian Use Device (HUD) designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

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