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

• Status: Withdrawn
• Trial end date: 2017-05-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Institute for Regenerative Medicine
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

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