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Trial record 17 of 17 for:    hrpe

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

This study has been terminated.
(Changes to the study design and the cell line)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Institute for Regenerative Medicine )
ClinicalTrials.gov Identifier:
NCT02563782
First received: September 21, 2015
Last updated: June 2, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Age-Related Macular Degeneration Biological: Sub-retinal transplantation of MA09-hRPE cells Drug: tacrolimus and mycophenolate mofetil Drug: Placebo tacrolimus and mycophenolate mofetil Procedure: Sham Surgery Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc ( Astellas Institute for Regenerative Medicine ):

Primary Outcome Measures:
  • Number of subjects with evidence of graft failure or rejection. [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • 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


Enrollment: 8
Actual Study Start Date: August 24, 2015
Study Completion Date: May 5, 2017
Primary Completion Date: May 5, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control group
Sham surgery and placebo immunosuppressive therapy (IMT)
Drug: Placebo tacrolimus and mycophenolate mofetil
placebo
Procedure: Sham Surgery
Sham surgery
Active Comparator: Active Group
Sub-retinal transplantation of MA09-hRPE cells and IMT
Biological: Sub-retinal transplantation of MA09-hRPE cells
transplantation
Drug: tacrolimus and mycophenolate mofetil
Immunosuppressive Agents

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.
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02563782

Locations
United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Astellas Institute for Regenerative Medicine
Investigators
Study Director: Medical Director Astellas Institute for Regenerative Medicine
  More Information

Responsible Party: Astellas Institute for Regenerative Medicine
ClinicalTrials.gov Identifier: NCT02563782     History of Changes
Other Study ID Numbers: 7317-CL-0002
MA09-hRPE AMD 02 PORTRAY ( Other Identifier: Sponsor )
Study First Received: September 21, 2015
Last Updated: June 2, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Tacrolimus
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 27, 2017