Phase 2 Clinical Trial

The Phase 2 clinical trial is a multicenter randomized clinical trial.  The purpose of this trial is to determine if NT-501 is an effective therapy for Macular Telangiectasia type 2.

The Phase 2 study measures the change in the area of the ellipsoid zone (inner segment/outer segment) break in eyes that receive the implant.  The ellipsoid zone is seen in OCT pictures as a bright white line.  It is thought to be made up mainly of mitochondria that are found within the ellipsoid layer of the outer portion of photoreceptor inner segments.  In a normal retina, the ellipsoid zone appears unbroken.  In an OCT picture of a MacTel eye, this line often appears broken.

An increase in the area of the ellipsoid zone break is a measure of disease progression. The clinical trial measures changes in the area of the ellipsoid zone break, over time, in all participants.  Participants also have visual function tests and retinal imaging done.

Patients randomly receive either a surgical NT-501 implant, or a sham procedure (no implant).   If both eyes were eligible for the trial, one eye is randomized to receive the implant and the other eye has a sham procedure.

The study is being conducted at eight sites in the United States and three in Australia.  There are 67 persons enrolled in the trial; almost half of the enrolled participants underwent bilateral procedures, with one eye receiving the implant and the other the sham procedure.

The Phase 2 clinical trial is fully enrolled.  No new participants may join the trial.  Study results will be analyzed after April 2016, once all participants have completed their second annual follow-up exam.

For more information, please visit the global clinical trials registry (www.clinicaltrials.gov)

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