NCT03102138

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
23mo left

Started Apr 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Apr 2024Jun 2028

First Submitted

Initial submission to the registry

September 22, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
7 years until next milestone

Study Start

First participant enrolled

April 16, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

3.1 years

First QC Date

September 22, 2016

Last Update Submit

November 19, 2024

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • incidence of serious adverse events and ocular adverse events

    incidence of serious adverse events and ocular adverse events will be monitored

    4 years

Secondary Outcomes (2)

  • Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA)

    4 years

  • Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints.

    4 years

Study Arms (1)

observation

subjects treated in B4711001 with PF-05206388 will be assessed

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with AMD treated in main study

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

London, London, EC1V 2PD, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Lyndon da Cruz

    Moorfields Eye Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2016

First Posted

April 5, 2017

Study Start

April 16, 2024

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

GB(1)