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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT02563782

Run by

Astellas Institute for Regenerative Medicine

People needed

0

Starts

2015-08-24

Expected to finish

2017-05-05

Last updated by the study team

2017-07-26

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Wills Eye Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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