Positive Results from Dry AMD (Geographic Atrophy) Study
Summary: The Retina Foundation of the Southwest took the lead in a multi-center research study sponsored by Neurotech Pharmaceuticals, Inc. The study involved monitoring patients with dry age-related macular degeneration (AMD) involving geographic atrophy—an eye disease that disrupts sharp central vision, resulting in severe vision loss in one or both eyes. Patients had a small capsule (named NT-501 by Neurotech) implanted in one eye. The implant supplies dosages of a growth factor called ciliary neurotrophic factor (CNTF) directly to the back of the patient’s eye in a controlled and continuous fashion. CNTF is a growth factor known to rescue and protect dying photoreceptors. Patients were randomized to one of three groups that received varying levels of dosage—high dose, low dose, and a sham treatment.
After 12 months, the study showed significant results. The NT-501 implant slowed the loss of vision at a much higher rate for patients treated with the implant versus patients with the sham-treatment. We were also able to show that the implants were producing therapeutic levels of CNTF after 12 months in the eye. These results are consistent with results from Phase I trials, validating the effectiveness of the NT-501 implant as treatment for patients affected by dry AMD. Moreover, the results of this Phase 2 trial extend the work by demonstrating the ability of the NT-501 implant to preserve vision in these patients.
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Results from Phase II Retinitis Pigmentosa Study
Summary: The Retina Foundation of the Southwest conducted a study in partnership with Neurotech Pharmaceuticals to test the effect of their product, the NT-501 eye implant, in patients with early stage Retinitis Pigmentosa. RP is an eye disease that gradually produces severe vision loss by destroying rod and cone photoreceptor cells in the retina. Patients suffer a drop in peripheral and night vision and eventually their central vision, leading to blindness. In the study, all patients received an implant—either a high or low dose in one eye and a sham treatment in the control eye.
Presently, all patients have been followed for at least 12 months. The implant produced a significant increase in retinal thickness involving photoreceptor layers relative to the amount of dose received. Although the thickening of the retina was observed at a statistically significant level, there was no trend in visual benefit observed after 12 months “possibly due to the slow progression of the disease…These patients will continue to be monitored for an additional 6 to 18 months per protocol.” Nonetheless, it is the researchers’ hope that the biologic effect of the implant observed in patients with RP will lead to a slowing down of the disease in the treated eye or even improvement as time progresses.
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Visual Acuity Development After the Implantation of
Unilateral Intraocular Lenses in Infants and Young Children
Summary: Researchers at the Retina Foundation completed a study that compared the effectiveness of intraocular lenses (IOLs) to aphakic contacts lenses (CLs) to improve visual function in infants with cataracts. A cataract is an opaque, cloudiness in the natural lens of the eye that disrupts the formation of sharp images to the retina. In an infant, a dense cataract deprives the child of any pattern vision, leaving them with only light perception. Currently, surgery to remove the cloudy lens is the only truly effective method of treating vision loss caused by cataracts. Once the natural lens is surgically removed, a replacement lens is needed to focus sharp images in the eye.
Until recently, most infants who had cataract surgery were fit with a contact lens. Implantation of an intraocular lens (IOL) is becoming an option for infants who undergo cataract surgery. IOLs are artificial lenses that are implanted in the eye in place of the surgically extracted natural lens. RFSW researchers have found that IOLs do just as good a job as the more commonly used contact lenses and that “IOLs may support better visual acuity development when compliance with contact lens wear is moderate to poor or when a cataract is extracted after 1 year of age.”
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Improvement in Motor Development following Surgery for Infantile Esotropia
Summary: Infantile esotropia is an eye abnormality that typically develops in the very early months of infancy. Children affected by esotropia experience an inward turning of one or both eyes away from the object of focus, resulting in a “cross-eyed” appearance and inability to perceive depth. This condition creates a significant delay in the child’ s ability to develop motor skills, such as grasping objects, walking and crawling. The researchers at the Retina Foundation took up the challenge in a collaborative effort to determine whether or not surgery yields a visual benefit and improvement in developmental skills for children affected by infantile esotropia. RFSW scientists developed a new questionnaire called the Infant Developmental Skills Survey (IDSS) to assess the state of the infants’ motor skills before surgery, after surgery, or both.
At the completion of a study, it was discovered that surgical treatment within the 4-10 month old range produces an improvement in visuomotor function. The study found that as a result of surgery, the group “showed rapid development and possessed motor skills comparable to those of normal children, suggesting that early surgery is beneficial to both visual and motor development.”
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Maturation of Visual Acuity is Accelerated in
Breast-Fed Term Infants Fed Baby Food Containing DHA-Enriched Egg Yolk
Summary: Researchers at the Retina Foundation of the Southwest investigated whether a specific nutrient, docosahexaenoic acid (DHA), is necessary to an infant’s weaning diet in order to optimize normal visual and neurological development. Prior research at the Retina Foundation of the Southwest found that DHA, naturally present in breast milk, played a significant role in visual maturation. Typically after 6 months, infants are weaned to solid foods. In the case of babies who were breast-fed, their intake of DHA would drop significantly as they began to consume solid foods due to the absence of the nutrient in commercial baby foods as well as the cereals, crackers, vegetables, and fruits that make up the bulk of their diet. “Human milk and supplemented infant formula are among the few foods available to infants in the US that contain a nutritionally relevant amount of DHA + ARA.”
Therefore, the researchers “utilized a randomized, clinical trial format to evaluate the effect of supplemental DHA in solid foods on visual development of breast-fed infants.” They sought to find whether there was a benefit to maintaining consistent intake of DHA even after breast-feeding by providing baby foods with DHA in jars. The results of the study supported the assertion that infants with higher levels of DHA had better visual acuity, or sharpness of vision, than infants with no supplementation. Stereoacuity, ability to detect differences in distance, was also evaluated in the study. However, there was “no benefit to stereoacuity attributable to DHA-enriched baby food.” In sum, “this trial demonstrates that the visual maturation of healthy infants is improved by continued supplies of DHA from both human milk and DHA-enriched baby foods well into 1 year of life.”
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