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Retinal Pigment Epithelium Safety Study For Patients In B4711001

Last updated on November 7, 2019

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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.
Show details

- 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 TitleRetinal Pigment Epithelium Safety Study For Patients In B4711001
Official TitleLONG 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 SummaryThis 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 DescriptionNot Provided
Study TypeObservational
Study DesignNot Provided
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionAge Related Macular Degeneration
InterventionNot Provided
Study Groups/Cohortsobservation
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 StatusActive, not recruiting
Actual Enrollment
 (submitted: October 1, 2019)
2
Original Estimated Enrollment
 (submitted: March 29, 2017)
10
Estimated Study Completion DateOctober 4, 2020
Estimated Primary Completion DateOctober 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
Ages60 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited Kingdom
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03102138
Other Study ID NumbersB4711005
2015-002267-42 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot 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 PartyMoorfields Eye Hospital NHS Foundation Trust
Study SponsorMoorfields Eye Hospital NHS Foundation Trust
CollaboratorsNot Provided
Investigators
Principal Investigator:Lyndon da CruzMoorfields Eye Hospital NHS Foundation Trust
PRS AccountMoorfields Eye Hospital NHS Foundation Trust
Verification DateOctober 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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