A phase II study of implants of encapsulated human NTC-201 cells releasing ciliary neurotrophic factor (CNTF) in participants with geographic atrophy due to macular degeneration using visual acuity as the primary outcome. CNTF is a potent protective factor for retinal neurons, but until recently, there has been no way to provide slow steady release to the human retina. The drug cannot be taken orally because it is too big to cross the blood-retinal barrier. We are using a sustained-release capsule containing human retinal epithelial cells which have been genetically-transfected to produce CNTF. This study is attempting to determine whether sustained CNTF for 1 year prevents progression in eyes with geographic atrophy due to AMD.

RETINITIS PIGMENTOSA

A Phase II Clinical Trial to investigate the effectiveness and safety of high dose docosahexaenoic acid (DHA) in early-stage X-linked retinitis pigmentosa. This 4-year prospective, randomized, placebo-controlled trial has enrolled 64 male patients (age 7-32 y) from across the U.S. and Canada. Patient enrollment is complete. The study is designed to test whether the nutritional intervention will slow the loss of visual function associated with this degenerative disease and thus, provide an extended period of usable vision. This trial is a collaborative venture between Retina Foundation researchers (Hoffman, Birch, & Wheaton) and retinal specialists (Fish & Spencer) at Texas Retina Associates. The project is funded, in part by the U.S. Food and Drug Administration, Martek Biosciences, and the Foundation Fighting Blindness. A detailed description of the trial is posted on the U.S. government’s ClinicalTrials.gov website at http://clinicaltrials.gov/ct/show/NCT00100230?order=2.

Argus™ II retinal implant system by Second Sight feasibility protocol attempting to provide visual stimulation by implanting an artificial chip in patients with end stage retinitis pigmentosa. Artificial retinas have evolved to the point where it is time to carefully assess the benefits that they can provide to blind patients. The Argus system involves 60 electrodes placed on the retinal surface to “replace” degenerate photoreceptors. We are working extensively with a small number of blind patients to optimize the stimulation for each individual.

A phase II study of implants of encapsulated human NTC-201 cells releasing ciliary neurotrophic factor (CNTF) in participants with advanced retinitis pigmentosa using visual acuity as the primary outcome. As a potent protective agent, CNTF has been shown to prevent retinal degeneration in animal models of retinitis pigmentosa. In this trial, we are attempting to improve ventral vision in patients with fairly advanced retinitis pigmentosa.

A phase II study of implants of encapsulated human NTC-201 cells releasing ciliary neurotrophic factor (CNTF) in participants with retinitis pigmentosa using visual field sensitivity as the primary outcome. Using the same rationale as above, we are attempting to slow the constriction of visual field loss in young patients with retinitis pigmentosa. Patients have the encapsulated CNTF cells implanted in one eye, with the fellow eye serving as a control.

PEDIATRIC EYE RESEARCH

• Observational study of visual development in children with small, partial, or developmental cataracts to develop criteria for surgical decision-making
• Long-term visual, cognitive, and growth outcomes and LCP-supplementation of infant formula
• Development of allergy or asthma during the first 7 years of life in children who were fed LCP-supplemented infant formula
• Sensory and cognitive outcomes following strabismus surgery in adults
• Suppression and recovery from suppression following treatment of amblyopia

Read about Recent Results from Current Clinical Trials

Read about Completed Clinical Trials