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Retinal Pigment Epithelium Safety Study For Patients In B4711001

This study is currently recruiting participants.
Verified November 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT03102138
First Posted: April 5, 2017
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition
Age Related Macular Degeneration

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • incidence of serious adverse events and ocular adverse events [ Time Frame: 4 years ]
    incidence of serious adverse events and ocular adverse events will be monitored


Secondary Outcome Measures:
  • Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA) [ Time Frame: 4 years ]
    Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA). The Proportion of subjects with an improvement of 15 letters or more at all timepoints will be assessed

  • Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints. [ Time Frame: 4 years ]
    Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints will be assessed


Estimated Enrollment: 10
Actual Study Start Date: September 21, 2016
Estimated Study Completion Date: October 4, 2020
Estimated Primary Completion Date: October 4, 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
observation
subjects treated in B4711001 with PF-05206388 will be assessed

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102138


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
United Kingdom
Moorfields Eye Hospital NHS Foundation Trust Recruiting
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03102138     History of Changes
Other Study ID Numbers: B4711005
2015-002267-42 ( EudraCT Number )
First Submitted: September 22, 2016
First Posted: April 5, 2017
Last Update Posted: November 24, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases