Oxygen Therapy for Retinal Ischemia

NCT03730779 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Trials2018
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Ischemia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

O2 recieving

EXPERIMENTAL

Patients who receive hyperoxia

Drug: Hyperoxia

Interventions

Hyperoxia DRUG

Patients will receive nocturnal normobaric hyperoxia therapy

Also known as: Nocturnal normobaric hyperoxia

O2 recieving

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of retinal-ischemia related condition

You may not qualify if:

• Complicating other ocular condition
• History of smoking or lung conditions

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 5, 2018
• Study Start: November 30, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)