Age Related Macular DegenerationNCT03102138
Retinal Pigment Epithelium Safety Study For Patients In B4711001
An observational study of Age Related Macular Degeneration, run by Moorfields Eye Hospital NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- How many people
- 10 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Apr 2024to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AMD treated in main study
Who may be able to join
- 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.
Who cannot join
- there are no exclusion criteria
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
London, London, EC1V 2PD
Moorfields Eye Hospital NHS Foundation Trust
London
About this study
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
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.
- Conditions
- Age Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observation | subjects treated in B4711001 with PF-05206388 will be assessed |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of serious adverse events and ocular adverse events
incidence of serious adverse events and ocular adverse events will be monitored
Measured: 4 years
Secondary outcomes (2)
Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA)
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
Measured: 4 years
Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints.
Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints will be assessed
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start16 Apr 2024
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lyndon da Cruz, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102138
- Sponsor's protocol ID
- DACL1013
- Other IDs
- 2015-002267-42, 2015
- Status last verified
- Nov 2026
- First submitted
- 22 Sep 2016
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03102138
- Acronym / sponsor ID
- DACL1013
- Conditions
- Age Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation | – | –subjects treated in B4711001 with PF-05206388 will be assessed |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AMD treated in main study
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- there are no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA)
Time frame: 4 years
Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndon da Cruz principal investigator
Moorfields Eye Hospital NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration, run by Moorfields Eye Hospital NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of serious adverse events and ocular adverse events (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.