Diabetic Macular IschemiaPhase 1NCT00899587
Evaluation of the Effects of Oxygen Therapy and Enalapril for Diabetic Macular Ischemia
A Phase 1 study testing enalapril and oxygen in people with Diabetic Macular Ischemia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
In this study, patients were divided into 3 group with 35 cases including: 1.oxygen 2.enalapril 3.control. In the beginning of the study, best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), and optical coherence tomography (OCT) were measured. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Macular Ischemia
- What is being tested?
- enalapril and oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with diabetic macular ischemia
Who cannot join
- HTN > 1140/90 or HTN controlled by ACE inhibitors
- FBS > 200
- Severe anemia, COPD, cataract, HRPDR and diffuse macular edema
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran, Tehran Province, 166666
Masoud Soheilian, MD, +98 21 22585952, labbafi@hotmail.com
About this study
In this study, patients were divided into 3 group with 35 cases including: 1.oxygen 2.enalapril 3.control.
In the beginning of the study, best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), and optical coherence tomography (OCT) were measured. Patients in the oxygen group were given oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month. In the enalapril group, patients were given enalapril 5 mg every night and placebo was given for the patients in third group. At the end of first month the patients' vision was checked again and at the the end of the third month the first physical examinations were performed. In the first group, arterial blood gas (ABG) was taken before and after oxygen therapy as well.
- Conditions
- Diabetic Macular Ischemia
- Being tested
- enalapril, oxygen, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enalaprilDrug
enalapril 5 mg every night
oxygenOther
oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | Experimental | Not described Receives: Other: oxygen |
| Enalapril | Experimental | Not described Receives: Drug: enalapril |
| Control | Placebo comparator | Not described Receives: Drug: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular 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 1
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899587
- Sponsor's protocol ID
- 8753
- Status last verified
- May 2009
- First submitted
- 11 May 2009
- Last updated
- 12 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Oxygen Therapy and Enalapril for Diabetic Macular Ischemia
- ClinicalTrials.gov ID
- NCT00899587
- Acronym / sponsor ID
- 8753
- Conditions
- Diabetic Macular Ischemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- First posted
- 12 May 2009 (estimated)
- 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.
In this study, patients were divided into 3 group with 35 cases including: 1.oxygen 2.enalapril 3.control.
In the beginning of the study, best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), and optical coherence tomography (OCT) were measured. Patients in the oxygen group were given oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month. In the enalapril group, patients were given enalapril 5 mg every night and placebo was given for the patients in third group. At the end of first month the patients' vision was checked again and at the the end of the third month the first physical examinations were performed. In the first group, arterial blood gas (ABG) was taken before and after oxygen therapy as well.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxygen | Experimental | Other: oxygen |
| Enalapril | Experimental | Drug: enalapril |
| Control | Placebo comparator | Drug: placebo |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with diabetic macular ischemia
Key exclusion criteria (3 listed)
- HTN > 1140/90 or HTN controlled by ACE inhibitors
- FBS > 200
- Severe anemia, COPD, cataract, HRPDR and diffuse macular edema
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 |
|---|---|---|
| enalaprilenalapril 5 mg every night | Drug | Enalapril |
| oxygenoxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month | Other | Oxygen |
| placebo | Drug | Control |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing enalapril and oxygen in people with Diabetic Macular Ischemia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 3 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: status not confirmed, as of the sponsor's last update on 12 May 2009. 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 Iran. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Masoud Soheilian, MD (+982122585952, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 12 May 2009.