Ozurdex in Suboptimal Diabetic Macular Edema Patients

• Status: Not yet recruiting
• Trial end date: 2021-12-29
• Target enrollment: 0
• Participant gender: All

Summary

The primary focus of this study is to understand the anatomic and visual outcomes of patients with refractory and suboptimal treatment response diabetic macular edema (DME) using anti-vascular endothelial growth factor (VEGF) to Ozurdex, an intravitreal dexamethasone implant. Secondly, investigators aim to understand the differences in cytokine profiles in patients who respond differently to intravitreal anti-VEGF versus Ozurdex. The importance of this study is to identify biomarkers that may help predict patients' response to different treatment protocols. Currently, Ozurdex is not covered by provincial health benefit plans for patients with DME. Our results may help improve access to care for those who have suboptimal results with or refractory to intravitreal anti-VEGF treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uptown Eye Specialists

Criteria

Inclusion Criteria:

1. Treatment-native patients with DME secondary to type I or type II diabetes mellitus

2. Patients who require intravitreal anti-VEGF treatment

3. Able to understand English and complete a pain assessment

4. Suboptimal DME responders in patients who have received 3 or 6 eylea injections (non-cytokine group)

Exclusion Criteria:

1. Deafness or communication disorder, known Dementia, Severe COPD/Asthma (severe lung disorder), Severe OSA, Psychiatric or Anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery; all patients who may need translation, are illiterate, or unable to provide consent.

2. Pre-existing ocular pathology confounding outcome (i.e. uveitis, retinal vascular disease, macular degeneration etc.)

3. Pre-existing uncontrolled glaucoma/high IOP

4. Patients under 18