A Study Of Implantation Of Human Embryonic Stem Cell Derived Retinal Pigment Epithelium In Subjects With Acute Wet Age Related Macular Degeneration And Recent Rapid Vision Decline

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Pfizer
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01691261
First received: September 19, 2012
Last updated: June 24, 2014
Last verified: June 2014

September 19, 2012
June 24, 2014
December 2014
April 2017   (final data collection date for primary outcome measure)
  • Incidence and severity of adverse events. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01691261 on ClinicalTrials.gov Archive Site
  • Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an impovement of 15 letters or more [ Time Frame: at Weeks 1,2,4,8, 12,16, 36 & 52. ] [ Designated as safety issue: No ]
  • Mean change of best corrected visual acuity (BCVA) from baseline by study visit. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Position of PF-05206388 by serial biomicroscopic evaluation. [ Time Frame: at Weeks 1, 2, 4,8, 10, 12, 16, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Position and presence of pigmented Retinal Pigment Epithelium cells by serial fundus photography and SLO autofluorescence. [ Time Frame: at Weeks 4, 6, 10, 12, 16, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Placement of PF-05206388 by serial spectral domain Ocular CoherenceTomography (OCT) scan [ Time Frame: at Weeks 4, 8, 12, 16, 24, 36 and 52. ] [ Designated as safety issue: No ]
  • Change in liver and renal function by blood tests and liver ultrasound . [ Time Frame: at Weeks 24 and 52 ] [ Designated as safety issue: Yes ]
  • Change in leakage or perfusion in normal fundal vasculature and presence of abnormal vasculature by fundus fluorescein angiography. [ Time Frame: at Weeks 4, 8, 12, 24 and 52 ] [ Designated as safety issue: Yes ]
  • Change in central 30 degree of visual function by Humphrey Field test. [ Time Frame: at Weeks 4, 8, 12, 24 and 52 ] [ Designated as safety issue: No ]
  • Evidence of diffuse retinal and RPE toxicity by full field ERG and EOG. [ Time Frame: at Weeks 12 and 52 ] [ Designated as safety issue: Yes ]
  • Photoreceptor survival (indirect indication of RPE survival) by Adaptive Optics. [ Time Frame: at Weeks 16, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Functional survival of retinal photoreceptors by Nidekmicroperimetry over PF-05206388. [ Time Frame: at Weeks 4, 16, 36 and 52 ] [ Designated as safety issue: No ]
  • Change in reading speed by Minnesota (MN) Read test. [ Time Frame: at Weeks 4, 8, 16, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Change in thickness of RPE layer by B-mode orbital ultrasound. [ Time Frame: at Weeks 4, 8, 16, 24, 36 and 52 ] [ Designated as safety issue: Yes ]
  • Detection of alloactive T-cells and alloreactive antibodies (blood) . [ Time Frame: at Weeks 2, 4, 8 12, 24 and 52 ] [ Designated as safety issue: No ]
  • Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more [ Time Frame: at Weeks 1,2,4,8, 12,16, 36 & 52. ] [ Designated as safety issue: No ]
  • Mean change of best corrected visual acuity (BCVA) from baseline by study visit. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Position of PF-05206388 by serial biomicroscopic evaluation. [ Time Frame: at Weeks 1, 2, 4,8, 10, 12, 16, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Position and presence of pigmented Retinal Pigment Epithelium cells by serial fundus photography and SLO autofluorescence. [ Time Frame: at Weeks 4, 6, 10, 12, 16, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Placement of PF-05206388 by serial spectral domain Ocular CoherenceTomography (OCT) scan [ Time Frame: at Weeks 4, 8, 12, 16, 24, 36 and 52. ] [ Designated as safety issue: No ]
  • Change in liver and renal function by blood tests and liver ultrasound . [ Time Frame: at Weeks 24 and 52 ] [ Designated as safety issue: Yes ]
  • Change in leakage or perfusion in normal fundal vasculature and presence of abnormal vasculature by fundus fluorescein angiography. [ Time Frame: at Weeks 4, 8, 12, 24 and 52 ] [ Designated as safety issue: Yes ]
  • Change in central 30 degree of visual function by Humphrey Field test. [ Time Frame: at Weeks 4, 8, 12, 24 and 52 ] [ Designated as safety issue: No ]
  • Evidence of diffuse retinal and RPE toxicity by full field ERG and EOG. [ Time Frame: at Weeks 12 and 52 ] [ Designated as safety issue: Yes ]
  • Photoreceptor survival (indirect indication of RPE survival) by Adaptive Optics. [ Time Frame: at Weeks 16, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Functional survival of retinal photoreceptors by Nidekmicroperimetry over PF-05206388. [ Time Frame: at Weeks 4, 16, 36 and 52 ] [ Designated as safety issue: No ]
  • Change in reading speed by Minnesota (MN) Read test. [ Time Frame: at Weeks 4, 8, 16, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Change in thickness of RPE layer by B-mode orbital ultrasound. [ Time Frame: at Weeks 4, 8, 16, 24, 36 and 52 ] [ Designated as safety issue: Yes ]
  • Detection of alloactive T-cells and alloreactive antibodies (blood) . [ Time Frame: at Weeks 2, 4, 8 12, 24 and 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study Of Implantation Of Human Embryonic Stem Cell Derived Retinal Pigment Epithelium In Subjects With Acute Wet Age Related Macular Degeneration And Recent Rapid Vision Decline
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

In this Phase 1 trial of retinal pigment epithelium (RPE) replacement, the aim will be to evaluate the safety and feasibility/efficacy of treating subjects with wet age-related macular degeneration (AMD) in whom there is rapidly progressing vision loss

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
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.
 
Not yet recruiting
10
April 2017
April 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and /or post-menopausal female subjects aged 61 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.
Both
61 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Not Provided
 
NCT01691261
B4711001
Yes
Pfizer
Pfizer
University College, London
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP