NCT02645266Active, not recruiting
Mean Visual Acuity Changes Following Five Injections of Aflibercept
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 30 Dec 2015
- Start date
- May 2018
- Primary completion date
- Sept 2027
- Lead sponsor
- McMaster University
- Diseases
- Diabetic eye disease
- NCT number
- NCT02645266
What you commit to
- Study type: Interventional
- Planned participants: 48
- From May 2018 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous anti-VEGF intravitreal treatment in affected eye
- Actively taking systemic steroids
- Previous laser treatment for DME within last 3 months .
- Any ocular surgery within the last 3 months.
- Previous retina surgery( PPV, ERM surgery etc)
Other illness
- Ocular inflammatory disease or autoimmune disease
- Any other retinal condition( CRAO, CRVO, wAMD, geographic atrophy)
Other
- Unwilling to sign consent form
- Medically uncontrolled glaucoma
- Individuals with disabilities that prevent accurate vision testing
- Proliferative diabetic retinopathy
Who the study is looking for
- Diagnosis of DME by a retina specialist
- Age: 18 or older
- VA between 25 and 75 letters at baseline
- Treatment naïve
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Joseph's Healthcare Hamilton Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.