The POC 1 study was initiated during the project period. Recruitment began in September 2008 and the first participant was enrolled in October 2008. Currently, 6 patients have been enrolled and randomized. Furthermore, we have reached out to ophthalmology practices in the south central Pennsylvania region to assist with identifying potential participants. We expect our enhanced recruitment strategies to be fruitful in the upcoming project period.
We have developed the protocol for POC 2, and received approval for the study from our external advisory committee. The protocol and informed consent form for POC 2 were approved by the Data Safety and Monitoring Committee (DSMC).
Who benefits from this research?
Ultimately, the patient benefits from this research because this project lays the basic groundwork for the acceptance of new diagnostic tests for diabetic retinopathy, and the testing of future therapeutic agents for diabetic retinopathy.
Patient recruitment will continue for POC 1, and patient recruitment for POC 2 is poised to begin pending final approval from JDRF. Based upon feedback from industry, we plan to expand the patient population enrolled in the diagnostic module to include a cohort of patients with proliferative diabetic retinopathy and a cohort of patients with macular edema.
To best leverage the END DR study, we plan to follow the study population for 36 months of follow-up. One of the tests, frequency doubling perimetry, appears to be a prime candidate for a useful functional endpoint.
The next major initiatives are to conduct the POC 2 Study, to conduct additional proof-of-concept studies, and to conduct a detailed electrophysiological study of patients with diabetes both with and without retinopathy.