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Active Not Recruiting
NCT02645266
Mean Visual Acuity Changes Following Five Injections of Aflibercept
Conditions: Diabetic Macular Edema
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 48
Sponsor: McMaster University
Location: St. Joseph's Healthcare Hamilton Hamilton Ontario
Summary
Diabetic Macular Edema is a serious ocular consequence of poorly controlled diabetes. Even though significant research has been done to clarify the pathogenesis of DME, a clear causal pathway of the complication is of yet undetermined. However, there is some consensus among researchers that a cascade of inflammatory markers plays an important role in the disease process. The study hopes to better delineate the role these inflammatory markers play by investigating whether basal levels predict response or lack thereof to Aflibercept.
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of DME by a retina specialist
2. Age: 18 or older
3. VA between 25 and 75 letters at baseline
4. Treatment naïve
Exclusion Criteria:
1. Unwilling to sign consent form
2. Previous anti-VEGF intravitreal treatment in affected eye
3. Actively taking systemic steroids
4. Ocular inflammatory disease or autoimmune disease
5. Previous laser treatment for DME within last 3 months .
6. Any ocular surgery within the last 3 months.
7. Previous retina surgery( PPV, ERM surgery etc)
8. Medically uncontrolled glaucoma
9. Any other retinal condition( CRAO, CRVO, wAMD, geographic atrophy)
10. Individuals with disabilities that prevent accurate vision testing
11. Proliferative diabetic retinopathy
Source: ClinicalTrials.gov (NCT02645266). StuddyBuddy aggregates publicly available trial information.