New investigational implant for MacTel Type 2

COVID-19 update:

In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

Trial ID:: IRB-17-7052; Richard Lin, MD

There is currently no treatment for MacTel Type 2. The goal of this study is to evaluate the safety and effectiveness of an investigational implant, NT-501, to slow the progression of the disease.

This is a 2 year study that requires 9 visits.

Inclusion Criteria

Have been diagnosed with MacTel Type 2
Be at least 21 but less than 80 years of age
Have visual acuity of at least 20/80 in one eye

Exclusion Criteria

Have had anti-angiogenic injections (such as Avastin) in either eye
Have other eye diseases (mild diabetic changes may be acceptable)
Have other health conditions that would prevent having a surgical procedure
Be pregnant or nursing
Be HIV positive

Additional Info

The NT-501 is a very small device (about the size of a grain of rice) that is implanted in the back of the eye and releases a protein that may protect the eye from further damage. Previous studies show that the NT-501 device may slow the progression of MacTel Type 2.
The NT-501 device will be compared to a sham/placebo; nothing will be placed in the eye during the Sham procedure.
This study is randomized which means there is a 50/50 chance of receiving the implant or the Sham/placebo procedure.

Contact Info:

Shannon Cyhan
cyhan.shannon@scrippshealth.org