Conditions: Diabetic Macular Edema
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: no

Brief summary:
To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema

Detailed description:
Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules targeting vascular endothelial factor (VEGF). One potential advantage of a dexamethasone implant over specific VEGF antagonists is that steroids suppress production of multiple pro-permeability factors.

Our primary objective is to measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 1, 2, 3, and 4 months after intraocular injection of a dexamethasone implant.

Arms:
arm 1: Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16. arm 2: Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.

Interventions: intervention 1: Dexamethasone Implant intervention 2: Anti-VEGF injection
Intervention descriptions: intervention 1: Patients will receive a single injection of a dexmethasone implant intervention 2: Patients will receive PRN injections of an anti-VEGF agent

Protocol document: