New investigational implant for MacTel Type 2

COVID-19 update:

In response to the COVID pandemic, Scripps Health has either temporarily suspended or limited enrollment with appropriate precautions for all clinical trials. 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