Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With...
Retinitis PigmentosaCone Rod Dystrophy1 moreThis study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or Choroideremia are implanted with an Intelligent Retinal Implant Systeme. All subjects undergo ophthalmological examinations in predefined intervals after implantation. Ophthalmological examinations include funduscopy, slit lamp examination and OCT. All adverse events are recorded and analyzed. Efficacy is measured using functional vision and visual function tests before and after implantation as well as with the system on and system off.
Safety Study in Subjects With Leber Congenital Amaurosis
Leber Congenital AmaurosisThe purpose of this study is to determine whether gene transfer will be safe and effective in the treatment of Leber Congenital Amaurosis (LCA).
Clinical Trial of Gene Therapy for Leber Congenital Amaurosis Caused by RPE65 Mutations
Leber Congenital AmaurosisThe purpose of this clinical trial is to examine the safety of gene therapy for Lebers Congenital Amaurosis (LCA) caused by RPE65 mutations using a recombinant adeno-associated virus serotype 2 (rAAV2) vector carrying the human RPE65 (hRPE65) gene. Recently, three independent short-term gene therapy studies in humans with LCA due to RPE65 mutations were published, suggesting that subretinal delivery of rAAV virus carrying the RPE65 gene is safe. As a secondary outcome, improvement in visual function was observed in seven of the first nine treated patients. The proposed study is a similar open label, Phase I clinical trial of uniocular subretinal rAAV2-hRPE65 administration to individuals with RPE65-associated retinal disease. Two cohorts of three subjects each and one cohort of four subjects will be included in this trial. Cohort 1 and 2 will consist of individuals 18 years of age and older and Cohorts 3 will consist of individuals 8 years of age and older. In cohort 2, a larger volume of vector will be administered. Enrollment in Cohort 3 will begin only after confirming the safety of rAAV2-hRPE65 administration in the older group of participants.
Phase 1/2 Safety and Efficacy Study of AAV-RPE65 Vector to Treat Leber Congenital Amaurosis
Leber Congenital AmaurosisThe purpose of the study is to evaluate the safety and efficacy of an adeno-associated virus vector expressing RPE65 in patients with Leber congenital amaurosis caused by mutations in the RPE65 gene. Funding Source - FDA OOPD
Young Blind Child Melatonin Treatment Study
BlindnessThe primary goal of this study is to identify the presence of desynchronized circadian rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples, and to rule out any primary sleep disorders.
The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial
ObesityThe purpose of this study is to examine whether the extract of the green tea is effective on obese women.
Effectiveness of Interfaces Program to Promote Work Ability of People With Disabilities
Disabilities MentalDisabilities Physicalthe objectives of the study is to Evaluate the effectiveness of "The Interfaces Program" to promote person's components, performance and improving the work environment of people with disabilities.
Study to Evaluate QR-110 in Leber's Congenital Amaurosis (LCA) Due to the c.2991+1655A>G Mutation...
Leber's Congenital AmaurosisThe purpose of this study is to evaluate the safety and tolerability of QR-110 administered via intravitreal injection in subjects with LCA due to the CEP290 p.Cys998X mutation.
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
Retinopathy of PrematurityRetinal Detachment1 moreThe purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity.In this study ACULAR will be compared to a placebo (artificial tear). The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to severe ROP (grade II and above)by 50%.
Early Treatment Diabetic Retinopathy Study (ETDRS)
BlindnessDiabetic RetinopathyTo evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in delaying or preventing progression of early diabetic retinopathy to more severe stages of visual loss and blindness. To help determine the best time to initiate photocoagulation treatment in diabetic retinopathy. To monitor closely the effects of diabetes mellitus and of photocoagulation on visual function. To produce natural history data that can be used to identify risk factors and test etiologic hypotheses in diabetic retinopathy.