This trial is looking to recruit patients with diabetic macular edema (DME) to trial a new gene therapy, ADVM-022. This trial is aiming to measure the time it takes for DME to worsen. This trial is being carried out in Puerto Rico and the United States.
The details
DME affects up to 10% of people with diabetes and is caused by fluid accumulation in the eye. It is responsible for the loss of sight in these patients. Current treatment involves laser surgery or multiple injections in the eye with drugs like aflibercept (Eylea).
ADVM-022 is a gene therapy developed for the treatment of serious retinal vascular (blocking of blood vessels of the eyes) such as DME. It involves a genetically modified aflibercept. ADVM-022 has been designed to reduce the current treatment burden of multiple injections of anti-DME drugs.
This trial will evaluate the safety and effectiveness of ADVM-022 in patients with DME. The main outcome to be measured is the length of time it will take for the worsening of DME.
Who are they looking for?
There will be 33 patients enrolled in this trial. Patients will be included if they have diabetes and vision impairment due to DME.
Patients will be excluded from this trial if they have uncontrolled diabetes, diabetic complications in the previous 3 months or have started (or planning to start) intensive insulin treatment recently. Patients with significant heart disease, uncontrolled high blood pressure, and poor kidney function will also be excluded. Patients will be excluded if they have other eye disease apart from diabetic retinopathy. Patients who are currently pregnant, planning to get pregnant, or are breastfeeding are also excluded from this trial.
How will it work
There will be three groups in this trial. Groups 1 and 2 will receive an aflibercept injection and one of 2 doses of ADVM-022. Group 3 will receive an aflibercept injection and a placebo injection. All participants will receive additional aflibercept injections in case of DME progression.
Participants will be followed up for 48 weeks. Time to improvements and worsening of DME disease will be measured.
