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Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

Primary Purpose

Diabetic Retinopathy Visually Threatening

Status

Active

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

ILM Peeling

No ILM Peeling

About this trial

This is an interventional treatment trial for Diabetic Retinopathy Visually Threatening

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital La Carlota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group

Control Group

Arm Description

Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment

Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment

Outcomes

Primary Outcome Measures

Postoperative ERM Development

Postoperative Epiretinal Membrane Development

Secondary Outcome Measures

Visual Acuity

Rate of subjects achieving 20/50 or better Snellen visual acuity

Full Information

NCT ID

NCT04380064

First Posted

May 5, 2020

Last Updated

October 24, 2022

Sponsor

Rush Eye Associates

1. Study Identification

Unique Protocol Identification Number

NCT04380064

Brief Title

Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

Official Title

Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy for Tractional Retinal Detachment: a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

February 1, 2025 (Anticipated)

Study Completion Date

February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rush Eye Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy Visually Threatening

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Group

Arm Type

Experimental

Arm Description

Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment

Intervention Type

Procedure

Intervention Name(s)

ILM Peeling

Intervention Description

ILM peeling performed during primary PPV for PDR

Intervention Type

Procedure

Intervention Name(s)

No ILM Peeling

Intervention Description

ILM peeling not performed during primary PPV for PDR

Primary Outcome Measure Information:

Title

Postoperative ERM Development

Description

Postoperative Epiretinal Membrane Development

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Visual Acuity

Description

Rate of subjects achieving 20/50 or better Snellen visual acuity

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sloan Rush, MD

Organizational Affiliation

panhandle eye group

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital La Carlota

City

Montemorelos

State/Province

Nuevo Leon

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

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