Status:
UNKNOWN
Ozurdex in Suboptimal Diabetic Macular Edema Patients
Lead Sponsor:
Uptown Eye Specialists
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 endothe...
Detailed Description
Diabetic macular edema (DME) is the most common cause of vision loss in young patients with diabetes. Its pathophysiology starts with decreased retinal oxygen tension that manifests as retinal capilla...
Eligibility Criteria
Inclusion
- Treatment-native patients with DME secondary to type I or type II diabetes mellitus
- Patients who require intravitreal anti-VEGF treatment
- Able to understand English and complete a pain assessment
- Suboptimal DME responders in patients who have received 3 or 6 eylea injections (non-cytokine group)
Exclusion
- 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.
- Pre-existing ocular pathology confounding outcome (i.e. uveitis, retinal vascular disease, macular degeneration etc.)
- Pre-existing uncontrolled glaucoma/high IOP
- Patients under 18
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04856397
Start Date
May 25 2021
End Date
December 29 2021
Last Update
May 12 2021
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