Internal Limiting Membrane Peeling in Proliferative Diabe... | NCT04380064

Studies
Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

NCT04380064

Sponsor

Rush Eye Associates

Status

Unknown status

Last Update Posted

Nov 18, 2023Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Diabetic Retinopathy Visually Threatening

Interventions

ILM Peeling
No ILM Peeling

Countries

Mexico

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Actual

Primary Completion Date

Feb 1, 2025Estimated

Completion Date

Feb 1, 2025Estimated

First Submitted Date

May 5, 2020

First Submission Date that Met QC Criteria

May 5, 2020

First Posted Date

May 8, 2020Actual

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

Nov 15, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Subject/Participant Groups:

Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment

Detailed Description

Hypothesis:

Subjects undergoing ILM peeling during vitrectomy will have lower central macular thickness on OCT, fewer postoperative epiretinal membranes, and thereby better final visual acuity to control subjects Randomization: Subjects will be randomized according to a coin toss during PPV, once Grade 2 or Grade 3 vitreoretinal adhesion has been determined: heads undergo ILM peeling, while tails do not.

Number of Subjects: With study power of 80%, a significance level of 0.05, a sample size of 60 patients for each group was calculated.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Experimental	Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment	Procedure: ILM Peeling
Control Group	Active Comparator	Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment	Procedure: No ILM Peeling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ILM Peeling	Procedure	ILM peeling performed during primary PPV for PDR	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative ERM Development	Postoperative Epiretinal Membrane Development	6 months

Secondary Outcomes

Measure	Description	Time Frame
Visual Acuity	Rate of subjects achieving 20/50 or better Snellen visual acuity	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

Subject age is 18-85 years.
Subject consents to study participation and is capable of 6 months of follow-up.
The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to hand motions in the study eye.
The subject is determined to need a PPV for the indication of TRD (Grades 2 and 3).

Exclusion:

Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
Subject is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA in the study eye.
Subject has a significant corneal or cataract opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sloan Rush, MD	panhandle eye group	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Hospital La Carlota		Montemorelos	Nuevo León		Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided