Predictors of Treatment Response to Aflibercept and Aqueo... | NCT02441907

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

NCT02441907

Sponsor

Unity Health Toronto

Status

Completed

Last Update Posted

Sep 19, 2019Actual

Enrollment

16Actual

Phase

Phase 4

Conditions

Diabetic Macular Edema

Interventions

aflibercept

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015Actual

Primary Completion Date

Aug 2018Actual

Completion Date

Sep 2019Actual

First Submitted Date

May 8, 2015

First Submission Date that Met QC Criteria

May 8, 2015

First Posted Date

May 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2019

Last Update Posted Date

Sep 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Label	Type	Description	Intervention Names
aflibercept treatment	Other	aflibercept, 40 mg/mL Solution for Intravitreal Injection	Drug: aflibercept

Name	Type	Description	Arm Group Labels	Other Names
aflibercept	Drug		aflibercept treatment	Eylea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in cytokine levels (picograms per mL) between baseline aflibercept injection and at 1, 2, and 3 months		3 months

Secondary Outcomes

Measure	Description	Time Frame
Relation of baseline aqueous cytokine levels to baseline Snellen BCVA in response to aflibercept		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided