Retinal Imaging in CNTF -Releasing Encapsulated Cell Implant Treated Patients for Early-stage Ret… (NCT01530659) | Clinical Trial Compass
CompletedPhase 2
Retinal Imaging in CNTF -Releasing Encapsulated Cell Implant Treated Patients for Early-stage Retinitis Pigmentosa
United States22 participantsStarted 2012-01
Plain-language summary
This clinical trial is a single-site, 30 patient study for participants who have early stage retinitis pigmentosa, or Usher syndrome (type 2 or 3). Funding Source - FDA OOPD and Foundation Fighting Blindness.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Participant must be between 18 and 55 years of age.
✓. Participant must have a diagnosis of retinitis pigmentosa or Usher Syndrome type 2 or 3 (without profound deafness or cochlear implants).
✓. Participant must understand and sign the protocol informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
✓. Best-corrected visual acuity must be no worse than 20/63 (at least 59 letters).
✓. Participants must have clear natural lenses.
✓. Participants must have less than 6 diopters myopia.
✓. Participants must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and able to undergo all assessments and tests associated with the protocol.
✓. Females of childbearing potential (women with last menses \<1 year prior to screening) must agree to use an effective form of birth control from study onset until they complete the study.
Exclusion criteria
✕. Participant is medically unable to comply with study procedures or follow-up visits.
✕. Participant who has any of the following lens opacities: cortical opacity \> standard 3, posterior subcapsular opacity \> standard 3, or a nuclear opacity \> standard 3 as measured on the AREDS clinical lens grading system; or participant is pseudophakic or aphakic.
What they're measuring
1
Mean Change in Cone Spacing in Arcminutes (Z Score) of 2 Baseline Values Were Compared With Measurements Obtained at Post-op Month 36
✕. Participant has history of corneal opacification or lack of optical clarity.
✕. Participant has undergone LASIK surgery or other refractive surgery for either eye.
✕. Participant has nystagmus.
✕. Participant has greater than 6 diopters myopia.
✕. Participant has cystoid macular edema with cysts present within 4 degrees of the foveal center that prevent acquisition of at least 7 regions of interest with clear images of cone photoreceptors.
✕. Participant has fewer than 7 regions of interest (ROIs) present on 2 baseline AOSLO image montages.