International Consortium Investigating Early Vitrectomy i... | NCT02639507

Studies
International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients

NCT02639507

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 26, 2020Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Diabetes With Diabetic Retinopathy With Macular Edema

Interventions

Vitrectomy

Countries

United States

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

Mar 2020

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

Jun 2015

Primary Completion Date

Mar 2020Actual

Completion Date

Mar 2020Actual

First Submitted Date

Dec 22, 2015

First Submission Date that Met QC Criteria

Dec 22, 2015

First Posted Date

Dec 24, 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

Mar 24, 2020

Last Update Posted Date

Mar 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading to swelling of the central retina (macula), and decreased vision. Removing the vitreous gel with vitrectomy surgery is known to decrease the swelling caused by diabetes. Diabetic retinopathy is often treated with laser or injections of medicine in to the eye.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Name	Type	Description	Arm Group Labels	Other Names
Vitrectomy	Procedure

Measure	Description	Time Frame
average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women, > 18 years of age with type 1 or 2 diabetes mellitus diagnosed and treated by an endocrinologist, internist or family medicine physician
Background diabetic retinopathy
DME with central subfield thickness (CST) > 325 µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
HbA1c level of < 10.0 mg/dl
Previous cataract surgery with implantation of a stable posterior chamber intraocular lens or a phakic eye with 1+ (out of 4+ scale) or less lens opacification
Predominantly intact (80%) external limiting membrane (ELM) and photoreceptor inner/outer segment (IS/OS) lines within 500 µm of the fovea on horizontal and vertical SD-OCT scans
Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive.

Exclusion Criteria:

Intraocular anti-vascular endothelial growth factor (VEGF) injection within the previous 3 months
Systemic anti-VEGF or receptor tyrosine kinase inhibitor therapy within the previous 3 months
Intraocular corticosteroid injection within the previous 6 months
Peri-ocular corticosteroid injection within the previous 3 months
Vitreomacular traction on SD-OCT scan (epiretinal membrane is allowed)
Previous anterior or pars plana vitrectomy
Glaucoma (IOP of > 21 mmHg or regular use of more than 2 IOP lowering drugs)
Previous trabeculectomy
Likelihood of needing intraocular surgery within 6 months
Hard exudates involving the fovea
Proliferative diabetic retinopathy with any evidence of retinal traction
Cataract of grade 2+ or greater.

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

Eligible patients will have the following characteristics:

Background diabetic retinopathy.
Center involving macular edema with CST > 325 µm as measured by SD-OCT.
Predominantly intact (80%) ELM and IS/OS lines within 500 µm of the fovea on both horizontal and vertical SD-OCT scans.
Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Florida		Jacksonville	Florida	32224	United States
Mayo Clinic in Florida

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative