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A Study Of Implantation Of Retinal Pigment Epithelium In Subjects With Acute Wet Age Related Macular Degeneration

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Moorfields Eye Hospital NHS Foundation Trust
London, , EC1V 2PD United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Age Related Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01691261
Pfizer
Suspended
A Study Of Implantation Of Retinal Pigment Epithelium In Subjects With Acute Wet Age Related Macular Degeneration

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A Study Of Implantation Of Retinal Pigment Epithelium In Subjects With Acute Wet Age Related Macular Degeneration
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
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
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Age Related Macular Degeneration
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.
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
Intervention: Biological: PF-05206388
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
10
March 2017
March 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01691261
B4711001
2011-005493-37 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
University College, London
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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