NCT03660371

Brief Summary

Subjects undergoing ILM peeling during vitrectomy will have better visual acuity and lower rates of DME to control subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

September 4, 2018

Last Update Submit

November 20, 2021

Conditions

Diabetic RetinopathyMacular Edema

Outcome Measures

Primary Outcomes (1)

  • BCVA

    best-corrected visual acuity

    6 months

Study Arms (2)

PPV/MP

EXPERIMENTAL

Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

Procedure: PPV/MP

PPV without MP

ACTIVE COMPARATOR

Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

Procedure: PPV without MP

Interventions

PPV/MPPROCEDURE

Internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

PPV/MP
PPV without MPPROCEDURE

No internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

PPV without MP

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 reduced BCSVA from vitreous hemorrhaging without substantial vitreoretinal (VR) adhesion (Grades 0 and 1).

You may not qualify if:

  • 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 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 a retinal detachment 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital La Carlota

Montemorelos, Nuevo León, Mexico

Location

MeSH Terms

Conditions

Diabetic RetinopathyMacular Edema

Interventions

Predictive Value of Tests

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

Sensitivity and SpecificityEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sloan Rush

    panhandle eye group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

September 4, 2018

Primary Completion

March 4, 2020

Study Completion

March 4, 2020

Last Updated

December 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)