Retinal IschemiaPhase 4NCT03730779
Oxygen Therapy for Retinal Ischemia
A Phase 4 study testing Hyperoxia in people with Retinal Ischemia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The investigators will be using nocturnal normobaric hyperoxia therapy in patients with diagnoses of conditions related to retinal ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Ischemia
- What is being tested?
- Hyperoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2018to 1 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of retinal-ischemia related condition
Who cannot join
- Complicating other ocular condition
- History of smoking or lung conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
Official title: Normobaric Nocturnal Hyperoxia Therapy for Treating Ischemic-Related Retinal Conditions
The investigators will be using nocturnal normobaric hyperoxia therapy in patients with diagnoses of conditions related to retinal ischemia.
Read the 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.
- Conditions
- Retinal Ischemia
- Being tested
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperoxiaDrug
Also called Nocturnal normobaric hyperoxia
Patients will receive nocturnal normobaric hyperoxia therapy
| Study group | Role | What they receive |
|---|---|---|
| O2 recieving | Experimental | Patients who receive hyperoxia Receives: Drug: Hyperoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Best Corrected Visual Acuity as measured by ETDRS chart
Measured: 6 months
Macula Edema
Amount of ME present, as measured by OCT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start30 Nov 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Arroyo, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730779
- Sponsor's protocol ID
- Trials2018
- Status last verified
- Mar 2020
- First submitted
- 2 Nov 2018
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: If researchers wish to access IPD they may contact us with their request
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normobaric Nocturnal Hyperoxia Therapy for Treating Ischemic-Related Retinal Conditions
- ClinicalTrials.gov ID
- NCT03730779
- Acronym / sponsor ID
- Trials2018
- Conditions
- Retinal Ischemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| O2 recieving | Experimental | Drug: HyperoxiaPatients who receive hyperoxia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of retinal-ischemia related condition
Key exclusion criteria (2 listed)
- Complicating other ocular condition
- History of smoking or lung conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperoxiaAlso: Nocturnal normobaric hyperoxiaPatients will receive nocturnal normobaric hyperoxia therapy | Drug | O2 recieving |
Primary outcome
Best Corrected Visual Acuity
Time frame: 6 months
Best Corrected Visual Acuity as measured by ETDRS chart
Macula Edema
Time frame: 6 months
Amount of ME present, as measured by OCT
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: No. If researchers wish to access IPD they may contact us with their request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperoxia in people with Retinal Ischemia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.