![]() breaks in or wrinkling on the surface of the retina or detachment of the retina.development of a hole, thinning, or loss of function of the retina, separation of the layers in the center of the retina, loss of retinal cells and the choroid (the layer of blood vessels that lines the back of the eye), or bleeding in the retina.Changes in the retina (the thin layer of tissue in the back of the eye) that can lead to vision loss including:.Permanent decline in visual acuity, or the sharpness of central vision.Eye infections, including a serious infection inside of the eye called endophthalmitis, that may lead to blindness.The following serious side effects may occur during or after the administration of LUXTURNA: Each participant was evaluated 1 year after treatment to measure the effect of LUXTURNA.Participants followed a prescribed course of medication to reduce risks related to an immune response. ![]() LUXTURNA was administered to the participants' first eye, and 6-18 days later, LUXTURNA was administered to their second eye.Group was then treated 1 year after the first group. The first group was treatedīefore the second group in order to compare results between treated and untreated participants. Two groups of participants were treated with LUXTURNA, each at a different time. Were able to perform the Multi-Luminance Mobility Test within the light level range evaluated, but unable to pass at the darkest light level.Had visual acuity of 20/60 or worse in both eyes and/or visual field less than 20 degrees.Had enough remaining cells in the retina.Had a genetic diagnosis of mutations in both copies of the RPE65 gene.Participants were eligible for the clinical trial if they: The clinical trial included 31 participants, 4-44 years old.
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