Oxygen Therapy for Retinal Ischemia | NCT03730779

Studies
Oxygen Therapy for Retinal Ischemia

NCT03730779

Sponsor

Beth Israel Deaconess Medical Center

Status

Withdrawn

Last Update Posted

Mar 9, 2020Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Retinal Ischemia

Interventions

Hyperoxia

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of funding

Expanded Access Info

Start Date

Nov 30, 2018Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Jan 1, 2020Actual

First Submitted Date

Nov 2, 2018

First Submission Date that Met QC Criteria

Nov 2, 2018

First Posted Date

Nov 5, 2018Actual

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 5, 2020

Last Update Posted Date

Mar 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jorge Arroyo, Associate Professor of Ophthalmology, Beth Israel Deaconess Medical CenterPrincipal Investigator

Lead Sponsor

Beth Israel Deaconess Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators will be using nocturnal normobaric hyperoxia therapy in patients with diagnoses of conditions related to retinal ischemia.

Detailed Description

Patients who receive a diagnosis of a condition relate to retinal ischemia and who pass the eligibility criteria will receive an oxygen concentrator to use at home. They will report back in follow up monthly for three to six months.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
O2 recieving	Experimental	Patients who receive hyperoxia	Drug: Hyperoxia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperoxia	Drug	Patients will receive nocturnal normobaric hyperoxia therapy	O2 recieving

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best Corrected Visual Acuity	Best Corrected Visual Acuity as measured by ETDRS chart	6 months
Macula Edema	Amount of ME present, as measured by OCT	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of retinal-ischemia related condition

Exclusion Criteria:

Complicating other ocular condition
History of smoking or lung conditions

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02115	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

If researchers wish to access IPD they may contact us with their request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided