A Study of Implantation of Retinal Pigment Epithelium in Subjects with Acute Wet Age Related Macular Degeneration
NCT ID: NCT01691261
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2021-10-14
2024-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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University College, London
OTHER
Moorfields Eye Hospital NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Moorfields
Role: STUDY_DIRECTOR
Moorfields Eye Hospital NHS Foundation Trust
Locations
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Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2011-005493-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DACL1010
Identifier Type: -
Identifier Source: org_study_id
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