This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the NT-501 implants in participants with macular telangiectasia type 2.
Phase 3, prospective, multicenter, masked, sham-controlled study with the overall study objective to evaluate the efficacy and safety of NT-501 for the treatment of MacTel. Secondary objective was to evaluate the safety of NT-501 in participants with MacTel. This was a multicenter study conducted at 20 study centers in the United States, Australia, Germany, and the United Kingdom.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
119
Each NT-501 implant consisted of hCNTF-secreting NTC-201-6A.02 cells encapsulated within supportive matrices and surrounded by a semipermeable polymer membrane. The NTC-201-6A cells continuously secrete CNTF from the NT-501 implant into the vitreous cavity. Implanted by a qualified Health Care Professional.
The sham surgery involved a superficial conjunctival incision performed under local anesthetic and closure with a single suture.
The Rate of Change in the Area of EZ Area of Loss From Baseline Through Month 24
The rate of change in the area of EZ loss (IS/OS; macular photoreceptor loss) from baseline through month 24, as assessed using SD-OCT in the study eye of participants with MacTel.
Time frame: End point timeframe is through Month 24. Baseline, Month 6, 12, 16, 20 and 24. Month 6 was collected but not included in the primary analyses.
Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population)
Change from baseline in retinal sensitivity loss as measured by as measured by Macular Integrity Assessment (MAIA)
Time frame: Baseline through 24 months.
Monocular Reading Speed (mITT Population)
Change from baseline through Month 24 for Monocular reading speed assessed using International Reading Speed Texts (IReST) cards developed by the IReST Study Group 21
Time frame: Baseline through 24 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Retina Vitreous Assoc
Beverly Hills, California, United States
Retina Consultants of Southern Colorado, P.C.
Colorado Springs, Colorado, United States
Emory University Eye Center
Atlanta, Georgia, United States
Northwestern Medical Group
Chicago, Illinois, United States
Elman Retina Group, PA
Baltimore, Maryland, United States
Massachusetts Eye and Ear Infirmary Ophthalmology Clinical Research Office
Boston, Massachusetts, United States
New England Retina Consultants
Springfield, Massachusetts, United States
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
The Retina Institute
Chesterfield, Missouri, United States
...and 17 more locations