Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Patients With Persistent Diabetic Macular Edema Following Treatment With Ranibizumab: An Interventional Prospective Study

Sponsor
Unity Health Toronto
Study ID
NCT02651168
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • aflibercept — BIOLOGICAL
    EYLEA (aflibercept, solution for intravitreal injection) is a recombinant fusion protein consisting of portions of human Vascular Endothelial Growth Factor (VEGF) receptor 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.

Study Details

Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina. The retina is like the film of a camera and is located in the back of the eye. This condition can develop in diabetics where swelling results from leaking of fluid from the blood vessels of the eye, into the center of the retina, the macula. If left untreated, this can affect central. The current standard treatment for diabetic macular edema includes medications injected directly into the eye (intravitreal injections) and laser eye treatment. The drugs that are injected directly into the eye are known as anti-VEGF agents which help to reduce the leaking. This includes bevacizumab (Avastin®) and ranibizumab (Lucentis®). However, some patients do not respond well to these anti-VEGF treatments and will be given the option of switching to an another newer anti-VEGF medication, called aflibercept (Eylea®) that is approved to treat DME. A recent large study has demonstrated that aflibercept was as efficacious as other anti-VEGF therapies listed above and was even superior in patients with worse vision (Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema. N Engl J Med. 2015:150218140025008-150218140025008). The purpose of this study is to determine what factors affect the treatment response to aflibercept (amount of swelling reduction) for patients with diabetic macular edema, who were previously unresponsive to ranibizumab injections.

Key Dates

Start date
Mar 31, 2016
Status verified
Jan 2016
Primary completion
Mar 31, 2018
Completion
Jun 30, 2018

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: aflibercept
    aflibercept treatment aflibercept, 40 mg/mL Solution for Intravitreal Injection

Primary Outcome Measure

Change in cytokine levels (picograms per mL) in patients with DME who were previously non-responders to ranibizumab (non-responders) between baseline aflibercept injection. [ Time Frame: 1month, 2 months, 3 months ]

Central Contacts

Related Studies