Clinical trial
Mean Visual Acuity Changes Following Five Injections of Aflibercept and the Relationship Between Ocular and Serum Cytokine Levels and Mean Visual Acuity Gains in DME Patients
Name
BHC-RD-SOP-038
Description
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.
Trial arms
Trial start
2018-05-01
Estimated PCD
2024-09-01
Trial end
2024-12-01
Status
Active (not recruiting)
Treatment
Aflibercept Injection [Eylea]
Subjects will be administered 2.0mg Aflibercept intraocular injection each month for 5 consecutive months. After the 5th month, the serum cytokine levels in blood work will be assessed as well as patients's visual acuity, and eye pressures. Upon completion of the trial, patients will resume receiving the usual standard of care.
Arms:
Aflibercept Injection [Eylea] group
Other names:
Eylea treatment
Size
48
Primary endpoint
To determine change in BCVA from baseline to month 5 of aflibercept treatment
5 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2024-03-13
1 organization
Organization
McMaster University