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Retinal Pigment Epithelium Safety Study For Patients In B4711001

Last updated on February 21, 2020

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Study Location
Moorfields Eye Hospital NHS Foundation Trust
London, , EC1V 2PD United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Age Related Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.

- Previous participation in Protocol B4711001 and received treatment with PF-05206388.

- Subjects who are willing and able to comply with scheduled visits, and study
procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- there are no exclusion criteria

NCT03102138
Pfizer
Active, not recruiting
Retinal Pigment Epithelium Safety Study For Patients In B4711001

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Descriptive Information
Brief Title Retinal Pigment Epithelium Safety Study For Patients In B4711001
Official Title LONG TERM, OPEN-LABEL, SAFETY FOLLOW UP STUDY FOLLOWING TRANSPLANTATION OF PF-05206388 (HUMAN EMBRYONIC STEM CELL DERIVED RETINAL PIGMENT EPITHELIUM (RPE)) IN SUBJECTS WITH ACUTE WET AGE RELATED MACULAR DEGENERATION AND RECENT RAPID VISION DECLINE
Brief Summary This is a safety follow-up study. Patients enrolled in B4711001 will be followed for a further 4 years with regular visits to assess safety.
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Age Related Macular Degeneration
Intervention Not Provided
Study Groups/Cohorts observation
subjects treated in B4711001 with PF-05206388 will be assessed
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 1, 2019)
2
Original Estimated Enrollment
 (submitted: March 29, 2017)
10
Estimated Study Completion Date October 4, 2020
Estimated Primary Completion Date October 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Previous participation in Protocol B4711001 and received treatment with PF-05206388.
  • Subjects who are willing and able to comply with scheduled visits, and study procedures.

Exclusion Criteria:

  • there are no exclusion criteria
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03102138
Other Study ID Numbers B4711005
2015-002267-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible Party Moorfields Eye Hospital NHS Foundation Trust
Study Sponsor Moorfields Eye Hospital NHS Foundation Trust
Collaborators Not Provided
Investigators
Principal Investigator: Lyndon da Cruz Moorfields Eye Hospital NHS Foundation Trust
PRS Account Moorfields Eye Hospital NHS Foundation Trust
Verification Date October 2019

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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