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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01691261
Recruitment Status : Active, not recruiting
First Posted : September 24, 2012
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Moorfields Eye Hospital NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE September 19, 2012
First Posted Date  ICMJE September 24, 2012
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2012)
  • Incidence and severity of adverse events. [ Time Frame: 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. [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01691261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2015)
  • Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an impovement of 15 letters or more [ Time Frame: Weeks 1,2,4,8, 12,16, 36, 52 ]
  • Mean change of best corrected visual acuity (BCVA) from baseline by study visit. [ Time Frame: 52 weeks ]
  • Position of PF-05206388 by serial biomicroscopic evaluation. [ Time Frame: 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 [ Time Frame: Weeks 2, 4, 8, 10, 12, 16, 24, 36, 52 ]
  • Mean change from baseline in contrast sensitivity by Pelli Robson test [ Time Frame: Weeks 24, 52 ]
  • Change in liver and renal function by blood tests and liver ultrasound . [ Time Frame: Weeks 24 and 52 ]
  • 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 ]
  • Change in central 30 degree of visual function by Humphrey Field test. [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2012)
  • 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. ]
  • Mean change of best corrected visual acuity (BCVA) from baseline by study visit. [ Time Frame: 52 weeks ]
  • Position of PF-05206388 by serial biomicroscopic evaluation. [ Time Frame: at Weeks 1, 2, 4,8, 10, 12, 16, 24, 36 and 52 ]
  • 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 ]
  • Placement of PF-05206388 by serial spectral domain Ocular CoherenceTomography (OCT) scan [ Time Frame: at Weeks 4, 8, 12, 16, 24, 36 and 52. ]
  • Change in liver and renal function by blood tests and liver ultrasound . [ Time Frame: at Weeks 24 and 52 ]
  • 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 ]
  • Change in central 30 degree of visual function by Humphrey Field test. [ Time Frame: at Weeks 4, 8, 12, 24 and 52 ]
  • Evidence of diffuse retinal and RPE toxicity by full field ERG and EOG. [ Time Frame: at Weeks 12 and 52 ]
  • Photoreceptor survival (indirect indication of RPE survival) by Adaptive Optics. [ Time Frame: at Weeks 16, 24, 36 and 52 ]
  • Functional survival of retinal photoreceptors by Nidekmicroperimetry over PF-05206388. [ Time Frame: at Weeks 4, 16, 36 and 52 ]
  • Change in reading speed by Minnesota (MN) Read test. [ Time Frame: at Weeks 4, 8, 16, 24, 36 and 52 ]
  • Change in thickness of RPE layer by B-mode orbital ultrasound. [ Time Frame: at Weeks 4, 8, 16, 24, 36 and 52 ]
  • Detection of alloactive T-cells and alloreactive antibodies (blood) . [ Time Frame: at Weeks 2, 4, 8 12, 24 and 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of Implantation Of Retinal Pigment Epithelium In Subjects With Acute Wet Age Related Macular Degeneration
Official Title  ICMJE 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
Brief Summary Phase 1 trial of retinal pigment epithelium replacement in subjects with wet age-related macular degeneration in whom there is rapidly progressing vision loss
Detailed Description 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Age Related Macular Degeneration
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 5, 2018)
2
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2012)
10
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01691261
Other Study ID Numbers  ICMJE B4711001
2011-005493-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Moorfields Eye Hospital NHS Foundation Trust
Study Sponsor  ICMJE Moorfields Eye Hospital NHS Foundation Trust
Collaborators  ICMJE University College, London
Investigators  ICMJE
Study Director: Moorfields Pfizer
PRS Account Moorfields Eye Hospital NHS Foundation Trust
Verification Date October 2019

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