XXXX for macular @entity8721 type 2: results from a phase 1 safety trial.

@entity1 @entity8721 @entity7178
PURPOSE: To evaluate the safety and tolerability of intraocular delivery of @entity7178 ( @entity7178 ) using an encapsulated cell implant for the treatment of macular @entity8721 type 2. DESIGN: An open-label safety trial conducted in 2 centers enrolling 7 @entity1 with macular @entity8721 type 2. METHODS: The @entity1 's more severely affected eye (worse baseline visual acuity) received the high-dose implant of @entity7178 . @entity1 were followed for a period of 36  months. The primary safety outcome was a change in the parameters of the electroretinogram (ERG). Secondary efficacy outcomes were changes in visual acuity, en face measurements of the optical coherence tomography of the disruption in the ellipsoid zone, and microperimetry when compared with baseline. RESULTS: The ERG findings demonstrated a reduction in the amplitude of the scotopic b-wave in 4 @entity1 3  months after implantation (month 3). All parameters returned to baseline values by month 12 and remained so at month 36 with no clinical impact on dark adaptation. There was no change in visual acuity compared with baseline. The area of the defect as measured functionally by microperimetry and structurally by the en face OCT imaging of the ellipsoid zone loss appeared unchanged from baseline. CONCLUSIONS: The intraocular delivery of @entity7178 in the encapsulated cell implant appeared to be safe and well tolerated in eyes with macular @entity8721 type 2. Further evaluation in a randomized controlled clinical trial is warranted to test for efficacy.
