Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Treatment Naïve Patients With Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441907
• Other study ID #: Aflibercept Cytokine DME
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 vision. 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-Vascular Endothelial Growth Factor (anti-VEGF) agents which help to reduce the leaking. However, response in patients to these anti-VEGF drugs can vary and examination of predictive factors is required. This particular study examines cellular factors called cytokines in patients receiving aflibercept, a type of anti-VEGF drug, in the hopes of detecting changes in cytokines that can predict treatment response amongst groups of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged 18 years or above

• Presence of Non Proliferative Diabetic Retinopathy (NPDR)

• Treatment Naïve patients with DME with central macular thickness of 310µm or more on SD-OCT (cirrus)

• Subjects with Type I or II diabetes mellitis

• Willing and able to provide informed consent for participation in the study

Exclusion Criteria:

• Proliferative diabetic retinopathy in the study eye or PRP within the last 12 months or anticipated PRP in the next 6 months

• Uncontrolled glaucoma

• History of intraocular surgery within 3 months in the study eye

• History of vitrectomy surgery

• Laser treatment within 3 months of study eye

• Vitreomacular traction, epiretinal membrane or any other maculopathy in the study eye

• Prior intravitreal injection within the past 6 months

• Known allergy to the study drug or fluorescein

• History of stroke or AMI within 6 months of enrollment

• Patients receiving dialysis for renal failure

• Patients currently on systemic immunosuppression

• Patients on two or more class of medication for glaucoma in study eye

• Patients with tuberculosis

• Patients who are pregnant.

• Unwilling or unable to follow or comply with all study related procedures

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• aflibercept

Locations

Country	Name	City	State
Canada	St. Michael's Hospital Eye Clinic	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cytokine levels (picograms per mL) between baseline aflibercept injection and at 1, 2, and 3 months		3 months
Secondary	Relation of baseline aqueous cytokine levels to baseline Snellen BCVA in response to aflibercept		3 months