DME is the leading cause of blindness in diabetics and is estimated to affect over 2 million people globally.
It is characterised by retinal thickening from leaky blood vessels.
The Phase 1b/2a trial will evaluate the safety and efficacy of OPT-302 in DME patients in the U.S.
Patients being recruited
Following submission of the study protocol to the Food and Drug Administration, and ethics approval by the central Institutional Review Board, clinical trial sites have been activated with patients being recruited.
The multi-centre clinical trial in the U.S. and Australia has two parts.
Trial has two parts
First is a Phase 1b dose escalation of OPT-302 used in combination with the VEGF-A inhibitor Eylea®.
Second is a Phase 2a randomised, controlled dose expansion with treatment allocated in a 2:1 ratio to either OPT-302 with Eylea®, or Eylea® monotherapy.
The trial will enrol circa 117 patients with persistent central involved DME despite prior anti-VEGF-A therapy with each patient dosed on a monthly basis for three months via intravitreal injection.
Clinical program expanded
This marks the expansion of the clinical development program for OPT-302 into a second ocular indication and targets a severe complication of diabetes.
Primary analysis of data from the Phase 1b/2a clinical trial is anticipated in the first half of 2019.
Opthea’s program includes a Phase 2b clinical trial in wet age-related macular degeneration, which is underway.
These trials will enable Opthea to more broadly explore the therapeutic potential of OPT-302.
Opthea is a late stage biopharmaceutical company developing novel biologic therapies to treat back-of-the-eye diseases.