A Study Of Implantation Of Retinal Pigment Epithelium In Subjects With Acute Wet Age Related Macular Degeneration
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ClinicalTrials.gov Identifier: NCT01691261 |
Recruitment Status :
Recruiting
First Posted : September 24, 2012
Last Update Posted : August 22, 2022
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Condition or disease | Intervention/treatment | Phase |
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Age Related Macular Degeneration | Biological: PF-05206388 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1, Open-label, Safety and Feasibility Study of Implantation of Pf-05206388 (Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (Rpe) Living Tissue Equivalent) in Subjects With Acute Wet Age Related Macular Degeneration and Recent Rapid Vision Decline |
Actual Study Start Date : | October 14, 2021 |
Estimated Primary Completion Date : | October 10, 2023 |
Estimated Study Completion Date : | March 14, 2024 |

Arm | Intervention/treatment |
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Experimental: Treatment
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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Biological: PF-05206388
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. |
- Incidence and severity of adverse events. [ Time Frame: 52 weeks ]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
- Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more at Week 24. [ Time Frame: 24 weeks ]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.
- Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more [ Time Frame: Weeks 1,2,4,8, 12,16, 36, 52 ]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.
- Mean change of best corrected visual acuity (BCVA) from baseline by study visit. [ Time Frame: 52 weeks ]The mean difference between the baseline BCVA and final BCVA in ETDRS letters for all cases
- Position of PF-05206388 by serial biomicroscopic evaluation. [ Time Frame: Day 2 and Weeks 1, 2, 4, 8, 10, 12, 16, 24, 36, 52 ]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
- Position and presence of pigmented RPE cells by serial fundus photography [ Time Frame: Weeks 2, 4, 8, 10, 12, 16, 24, 36, 52 ]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
- Mean change from baseline in contrast sensitivity by Pelli Robson test [ Time Frame: Weeks 24, 52 ]The mean difference between the baseline BCVA and final BCVA in Pelli Robson letters read, across all subjects
- Change in liver and renal function by blood tests and liver ultrasound . [ Time Frame: Weeks 24 and 52 ]Record of any abnormalities in liver and renal function on blood testing and any abnormalities detected on the liver ultrasound.
- Change in leakage or perfusion in normal fundal vasculature and presence of abnormal vasculature by fundus fluorescein angiography. [ Time Frame: Weeks 4, 8, 12, 24 and 52 ]Assessment and noting of abnormalities on Funded fluorescine angiography at weeks 4, 8, 12, 24 and 52.
- Change in central 30 degree of visual function by Humphrey Field test. [ Time Frame: Weeks 4, 8, 12, 24 and 52 ]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
- Change in thickness of RPE layer by B-mode orbital ultrasound. [ Time Frame: Weeks 4, 8, 16, 24, 36, 52 ]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.

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and /or post-menopausal female subjects aged 60 years or above.
- Diagnosis of wet Age-related Macular Degeneration (AMD) plus rapid recent vision decline
- An informed consent document signed and dated by the subject or a legal representative.
Exclusion Criteria:
- Pregnant females; breastfeeding females; and females of childbearing potential.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- Current or previous significant other ocular disease in the study eye, as determined by the investigator.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691261
Contact: Tania West | 02072533411 ext 2036 | moorfields.resadmin@nhs.net | |
Contact: Daniela Narvaez | 02072533411 ext 2036 | moorfields.resadmin@nhs.net |
United Kingdom | |
Moorfields Eye Hospital NHS Foundation Trust | Recruiting |
London, United Kingdom, EC1V 2PD | |
Moorfields Eye Hospital NHS Foundation Trust | Recruiting |
London, United Kingdom, EC1V 2PD | |
Contact: Moorfields R&D 020 7253 3411 ext 2937 moorfields.resadmin@nhs.net |
Study Director: | Moorfields | Moorfields Eye Hospital NHS Foundation Trust |
Responsible Party: | Moorfields Eye Hospital NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT01691261 |
Other Study ID Numbers: |
B4711001 2011-005493-37 ( EudraCT Number ) |
First Posted: | September 24, 2012 Key Record Dates |
Last Update Posted: | August 22, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |