Retinal Pigment Epithelium Safety Study for Patients in B4711001
Active, not recruiting
- Conditions
- Age Related Macular Degeneration
- Registration Number
- NCT03102138
- Lead Sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- 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 available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of serious adverse events and ocular adverse events 4 years incidence of serious adverse events and ocular adverse events will be monitored
- Secondary Outcome Measures
Name Time Method Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints. 4 years Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints will be assessed
Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA) 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
Trial Locations
- Locations (1)
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
🇬🇧London, United Kingdom