DME Patient or Family Caregiver Resources

People with diabetes face a number of risks and complications. One of them is Diabetic Macular Edema (DME); a leading cause of diabetes-related vision loss. 

As of 2012, an estimated 9.6 million people in the United States alone had diabetic eye disease (diabetic retinopathy), with DME occurring in about 10% of patients.

What is DME?

DME involves the thickening of the central area of the retina (called the macula) resulting in a loss of visual acuity. In DME, the retina’s small blood vessels become leaky and allow fluid to accumulate in the retina and cause swelling (or edema). DME is caused by the damaging effects of elevated blood sugar level (hyperglycemia) that occur in diabetes. In addition, high blood pressure and changes in proteins in the eye can contribute to the development and worsening of this vision threatening condition.

What to expect

The American Diabetes Association recommends that people with diabetes should have eye exams regularly by an eye care professional. Early detection and treatment for any vision changes can significantly preserve sight. If you notice blurriness, waviness or a muting of colors in your vision, visit your eye doctor immediately. 

Ophthalmologists will use highly sensitive and non-invasive imaging technology, such as optical coherence tomography (OCT), to visualize the involvement of the macula and measure the thickening of the retina. They’ll also assess visual acuity through standardized eye chart tests.

Treatment for DME

Current treatments for DME include vascular endothelial growth factor (VEGF) inhibitors, corticosteroids and laser therapy. VEGF inhibitors block the actions of VEGF; a signaling protein that causes the retinal vessels to leak. Patients typically receive VEGF injection therapies once a month and can experience significant vision improvements from them. However, not all DME patients respond adequately to these treatments. 

Steroids improve vision to a lesser degree than anti-VEGF treatments and also increase the risk of cataracts and glaucoma. Laser therapy is used in conjunction with other treatments.

KalVista’s founding scientists, Edward P. Feener, PhD and Lloyd P. Aiello MD, PhD, from the Joslin Diabetes Center associated with Harvard Medical School, were pioneers in the discovery of a new mechanism potentially contributing to the development of DME. They found that plasma kallikrein - an enzyme - was excessively activated in patients with DME. Based upon that scientific finding, we pursued a plasma kallikrein inhibitor that could reduce those levels and, potentially, lessen the impact of DME. Our most advanced program in this effort, known as KVD001, is an intravitreally administered plasma kallikrein inhibitor that we are developing for DME. KVD001 has completed a Phase 2 clinical trial in patients with DME. The Phase 2 clinical trial study was designed to evaluate patients who were poor responders to previous treatment with anti-VEGF therapy. Although the study did not meet the primary endpoint, KVD001 demonstrated what we believe is an important dose responsive clinical benefit on vision in the overall population.

Our eventual goal is to develop an orally delivered therapeutic and improve upon the current DME drugs delivered via injection.