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Study to Evaluate Sub-retinal Transplantation of Retinal Pigmented Epithelial Cells in Patients With Dry AMD (PORTRAY)

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: NCT02563782
Recruitment Status : Withdrawn (Changes to the study design and the cell line)
First Posted : September 30, 2015
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Institute for Regenerative Medicine )

Tracking Information
First Submitted Date  ICMJE September 21, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date July 26, 2017
Actual Study Start Date  ICMJE August 24, 2015
Actual Primary Completion Date May 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
Number of subjects with evidence of graft failure or rejection. [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • Change in area of geographic atrophy by Optical coherence tomography [ Time Frame: 18 months ]
    Change from baseline to Week 78
  • Change in area of geographic atrophy by Autofluorescence [ Time Frame: 18 months ]
    Change from baseline to Week 78
  • Change in average Best Corrected Visual Acuity (BCVA) [ Time Frame: 18 months ]
    Change from baseline to Week 78
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Sub-retinal Transplantation of Retinal Pigmented Epithelial Cells in Patients With Dry AMD
Official Title  ICMJE Ph 2, Double-Masked, Randomized, Parallel, Sham Surgery/Placebo Control, Multi-Center Study to Evaluate Systemic IMT Regimens as Graft Rejection Prophylaxis Following Transplantation of hESC Derived RPE Cells in Patients With AMD
Brief Summary To evaluate the safety of 3 regimens of short-term, low-dose systemic IMT as rejection prophylaxis prior to and/or following transplant of MA09-hRPE cells.
Detailed Description This study will be a Phase 2, double-masked, randomized, parallel group, sham surgery/placebo control, multi-center trial. Subjects will be randomized in a 3:1 ratio to either the treatment or control group respectively. Subjects randomized to the treatment group will receive transplantation with 200,000 MA09-hRPE (human embryonic stem cell derived retinal pigmented epithelial)cells in one eye. Subjects randomized to the control group will have a sham surgery without transplantation of MA09-hRPE cells. The study eye must meet all eligibility criteria. If both eyes meet all eligibility criteria, then the study eye will be the eye with the worst Best Corrected Visual Acuity (BCVA) score at screening. If both eyes have identical BCVA scores, then the study eye will be chosen by the Investigator and the subject. There will be 3 cohorts, each with a different regimen of low-dose IMT [tacrolimus and mycophenolate mofetil (MMF)]. Subjects will be randomized to treatment or control within cohorts, defined by severity of BCVA in the study eye at Screening. Enrollment in Cohort 1 and 2 will be concurrent. Enrollment into Cohort 3 will begin once Cohort 2 is fully enrolled.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE
  • Biological: Sub-retinal transplantation of MA09-hRPE cells
    transplantation
  • Drug: tacrolimus and mycophenolate mofetil
    Immunosuppressive Agents
  • Drug: Placebo tacrolimus and mycophenolate mofetil
    placebo
  • Procedure: Sham Surgery
    Sham surgery
Study Arms  ICMJE
  • Sham Comparator: Control group
    Sham surgery and placebo immunosuppressive therapy (IMT)
    Interventions:
    • Drug: Placebo tacrolimus and mycophenolate mofetil
    • Procedure: Sham Surgery
  • Active Comparator: Active Group
    Sub-retinal transplantation of MA09-hRPE cells and IMT
    Interventions:
    • Biological: Sub-retinal transplantation of MA09-hRPE cells
    • Drug: tacrolimus and mycophenolate mofetil
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 25, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2015)
60
Actual Study Completion Date  ICMJE May 5, 2017
Actual Primary Completion Date May 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Geographic atrophy (GA) secondary to AMD with no evidence of prior to active choroidal neovascularization (CNV) in the study eye.
  • BCVA in the study eye must be between 4 and 58 Early Treatment of Diabetic Retinopathy Study (EDTRS) letters (20/800 to 20/80; 0.025-0.25)
  • Subjects must be willing to take IMT and willing to discontinue any medication that has a known strong interaction with tacrolimus or mycophenolate mofetil (MMF)

Exclusion Criteria:

  • Macular atrophy due to causes other than AMD
  • Other sight-threatening ocular disease
  • Current or prior history of optic neuropathy, retinal dystrophy, retinitis pigmentosa, chorioretinitis, vasoocclusive disease, retinal vascular disease or retinal degenerative disease OTHER than AMD
  • History of uveitis
  • History of allergic reaction to sulfa drugs
  • Solid organ or bone marrow transplant recipient
  • History of malignancy within the previous 5 years (except for BCC (basal cell carcinoma), SCC (squamous cell carcinoma) or in-situ cervical)
  • History of myocardial infarction with past 12 months
  • History of clinically significant cardiac dysrhythmia
  • History of diabetes mellitus, bowel disease, tuberculosis
  • Prior treatment for non-exudative AMD
  • Intraocular, refractive or cataract surgery in the last 12 weeks
  • Prior retinal surgery, vitrectomy, macular laser photocoagulation, external beam radiation therapy, transpupillary thermotherapy, glaucoma filtration surgery or corneal surgery (except cataract surgery)
  • Receipt of gene transfer of cell transplant therapy in a prior clinical trial
  • Participation in any other interventional clinical trial within the last 12 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (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 States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563782
Other Study ID Numbers  ICMJE 7317-CL-0002
MA09-hRPE AMD 02 PORTRAY ( Other Identifier: Sponsor )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Astellas Pharma Inc ( Astellas Institute for Regenerative Medicine )
Study Sponsor  ICMJE Astellas Institute for Regenerative Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Astellas Institute for Regenerative Medicine
PRS Account Astellas Pharma Inc
Verification Date July 2017

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