Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Retinal Pigment Epithelium Safety Study For Patients In B4711001

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102138
Recruitment Status : Active, not recruiting
First Posted : April 5, 2017
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease
Age Related Macular Degeneration

Layout table for study information
Study Type : Observational
Actual Enrollment : 2 participants
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
Actual Study Start Date : September 21, 2016
Estimated Primary Completion Date : October 4, 2020
Estimated Study Completion Date : October 4, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
observation
subjects treated in B4711001 with PF-05206388 will be assessed



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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



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.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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

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


Locations
Layout table for location information
United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03102138     History of Changes
Other Study ID Numbers: B4711005
2015-002267-42 ( EudraCT Number )
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (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/data_requests.
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases