Mean Visual Acuity Changes Following Five Injections of Aflibercept

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: McMaster University
• Treatments: Aflibercept

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