This trial is being carried out to assess the effectiveness of a port delivery system (PDS) loaded with ranibizumab (Lucentis) in order to prevent further progression of diabetic retinopathy (DR; diabetic eye disease). The main outcome of this trial is to assess the improvement in DR following implantation with a PDS. This trial is being carried out in the United States and Puerto Rico.
The details
DR is a complication of diabetes that affects the eyes. It is caused by damage to the blood vessels of the light-sensitive tissue in the back of the eye responsible with sight. This causes progressive vision loss and eventually results in complete blindness if not treated. Standard treatment is with ranibizumab. it is usually delivered by injection.
PDS with ranibizumab is a permanent refillable eye implant that continuously delivers ranibizumab over a period of months, potentially reducing the treatment burden associated with frequent eye injections.
This trial will evaluate the effectiveness of a PDS with ranibizumab in patients with DR. The main outcome that will be measured is baseline improvement in DR.
Who are they looking for?
This trial is looking to recruit 160 patients with diabetes mellitus and moderate or severe DR. Participants must have an HbA1c (measure of blood glucose control over the past 2-3 months) level below 12% within 2 months prior to or at the beginning of the study.
Patients will be exlcluded from the trial if they have uncontrolled blood pressure, have had a heart attack, stroke or an abnormal heart rhythm within 6-months prior to starting this trial. Participants with kidney failure, an infection that needs treatment, or another condition that interferes with the PDS implant will also be excluded.
How will it work
There will be two groups in this study. Group 1 receive the PDS implant following two ranibizumab injections. Group 2 will receive a PDS implant after 4-weeks of clinical monitoring. Refilling of the PDS will be carried out every 36-weeks in both groups.
The main outcome measured will be improvements in DR scales. Patients will be followed up over a time-frame of between 52-weeks to 112-weeks.
