Age Related Macular Degeneration
Conditions
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.
Interventions
None listed
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of serious adverse events and ocular adverse events | 4 years | incidence of serious adverse events and ocular adverse events will be monitored |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed