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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005493-37 | EudraCT Number |
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| Name | Class |
|---|---|
| University College, London | OTHER |
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Phase 1 trial of retinal pigment epithelium replacement in subjects with wet age-related macular degeneration in whom there is rapidly progressing vision loss
Phase 1, open-label, safety and feasibility study of implantation of PF-05206388 (human embryonic stem cell derived retinal pigment epithelium) in subjects with wet age related macular degeneration and rapid vision loss
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | PF-05206388 Retinal Pigment Epithelium living tissue equivalent for intraocular use in the form of a monolayer of Retinal Pigmented Epithelial (RPE) cells immobilized on a polyester membrane |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05206388 | Biological | PF-05206388 will be provided as a Retinal Pigment Epithelium living tissue equivalent for intraocular use in the form of a monolayer of Retinal Pigmented Epithelial (RPE) cells immobilized on a polyester membrane. The membrane is approximately 6 mm x 3 mm and will contain a confluent layer of RPE cells, at a nominal dose of 17 mm2. The implant is intended to be life-long. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events. | The number of Adverse Events (AE) and Serious Adverse Events (SAE) noted during the study and an assessment of whether they are trial product related | 52 weeks |
| Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more at Week 24. | The number of patients with a difference between the baseline BCVA and BCVA at 24 weeks in ETDRS letters, where the differences is 15 letters or more, as a percentage of the total number of cases. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more | The number of patients with a difference between the baseline BCVA and BCVA at weeks 1,2,4,8, 12,16, 36, 52 in ETDRS letters, where the differences is 15 letters or more, as a percentage of the total number of cases. | Weeks 1,2,4,8, 12,16, 36, 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moorfields | Moorfields Eye Hospital NHS Foundation Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moorfields Eye Hospital NHS Foundation Trust | London | EC1V 2PD | United Kingdom |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 18, 2025 | |
| Reset | Jan 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 18, 2025 | Jan 9, 2026 | |||
| Jun 30, 2026 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Mean change of best corrected visual acuity (BCVA) from baseline by study visit. | The mean difference between the baseline BCVA and final BCVA in ETDRS letters for all cases | 52 weeks |
| Position of PF-05206388 by serial biomicroscopic evaluation. | Measurement of movement in millimetre and rotation in degrees measure relative to baseline, at day 2 and weeks 1, 2, 4, 8, 10, 12, 16, 24, 36 and 52 | Day 2 and Weeks 1, 2, 4, 8, 10, 12, 16, 24, 36, 52 |
| Position and presence of pigmented RPE cells by serial fundus photography | The subjective reporting of area of pigmentation as a % with cross reference to the OCT at weeks 2, 4, 8, 10, 12, 16, 24, 36 and 52 | Weeks 2, 4, 8, 10, 12, 16, 24, 36, 52 |
| Mean change from baseline in contrast sensitivity by Pelli Robson test | The mean difference between the baseline BCVA and final BCVA in Pelli Robson letters read, across all subjects | Weeks 24, 52 |
| Change in liver and renal function by blood tests and liver ultrasound . | Record of any abnormalities in liver and renal function on blood testing and any abnormalities detected on the liver ultrasound. | Weeks 24 and 52 |
| Change in leakage or perfusion in normal fundal vasculature and presence of abnormal vasculature by fundus fluorescein angiography. | Assessment and noting of abnormalities on Funded fluorescine angiography at weeks 4, 8, 12, 24 and 52. | Weeks 4, 8, 12, 24 and 52 |
| Change in central 30 degree of visual function by Humphrey Field test. | Recording and reporting of any changes on the central 30 degree field on the automated Humphrey Field test at weeks 4, 8, 12, 24 and 52 | Weeks 4, 8, 12, 24 and 52 |
| Change in thickness of RPE layer by B-mode orbital ultrasound. | Recording of any changes in thickness of RPE layer by B-mode orbital ultrasound carried out by the ocular oncologist or medical physicist at weeks 4, 8, 16, 24, 36, 52. | Weeks 4, 8, 16, 24, 36, 52 |