Astellas Macular Degeneration trial on clinicaltrials.gov
May 31, 2017 4:59:01 GMT
JHam and kukkido like this
Post by imz72 on May 31, 2017 4:59:01 GMT
Some notable details from clinicaltrials.gov/show/NCT03167203:
A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy
This study is not yet open for participant recruitment.
Sponsor: Astellas Institute for Regenerative Medicine
Purpose: The purpose of this study is to is to evaluate the occurrence of late onset (i.e., greater than 5 years after treatment) safety events of special interest in participants who have received sub-retinal transplant of human embryonic stem cell derived - retinal pigment epithelial (hESC-RPE) cells in an AIRM-sponsored clinical trial. The events of special interest are adverse events (AEs) that are presumed to have a potential causal relationship to the hESC-RPE cells.
Estimated Enrollment: 37
Anticipated Study Start Date: May 31, 2017
Estimated Study Completion Date: December 31, 2029
Estimated Primary Completion Date: December 31, 2029 (Final data collection date for primary outcome measure)
Detailed Description: Participants will be contacted by the Patient Outreach Center (POC) on an annual basis to complete a questionnaire about the occurrence of safety events of special interest, as defined in the Outcome Measure section.
The questionnaire will be completed directly by the participant (via a secure web based platform) or will be administered via telephone by a POC staff member. In the event of the occurrence of a safety event of special interest, study participant will be encouraged to contact the POC as soon as possible, rather than wait for the annual questionnaire completion. Follow up data is inclusive of the 1 year in the core trial, 4 years in the long term follow up trial and 10 years in this long term safety follow up. Participation for United Kingdom participants will be life-long.
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Study First Received: May 24, 2017
Last Updated: May 24, 2017
ClinicalTrials.gov processed this record on May 30, 2017
A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy
This study is not yet open for participant recruitment.
Sponsor: Astellas Institute for Regenerative Medicine
Purpose: The purpose of this study is to is to evaluate the occurrence of late onset (i.e., greater than 5 years after treatment) safety events of special interest in participants who have received sub-retinal transplant of human embryonic stem cell derived - retinal pigment epithelial (hESC-RPE) cells in an AIRM-sponsored clinical trial. The events of special interest are adverse events (AEs) that are presumed to have a potential causal relationship to the hESC-RPE cells.
Estimated Enrollment: 37
Anticipated Study Start Date: May 31, 2017
Estimated Study Completion Date: December 31, 2029
Estimated Primary Completion Date: December 31, 2029 (Final data collection date for primary outcome measure)
Detailed Description: Participants will be contacted by the Patient Outreach Center (POC) on an annual basis to complete a questionnaire about the occurrence of safety events of special interest, as defined in the Outcome Measure section.
The questionnaire will be completed directly by the participant (via a secure web based platform) or will be administered via telephone by a POC staff member. In the event of the occurrence of a safety event of special interest, study participant will be encouraged to contact the POC as soon as possible, rather than wait for the annual questionnaire completion. Follow up data is inclusive of the 1 year in the core trial, 4 years in the long term follow up trial and 10 years in this long term safety follow up. Participation for United Kingdom participants will be life-long.
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Study First Received: May 24, 2017
Last Updated: May 24, 2017
ClinicalTrials.gov processed this record on May 30, 2017
