NCT00899587

Brief 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. 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.

Trial Health

55
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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

May 12, 2009

Status Verified

May 1, 2009

First QC Date

May 11, 2009

Last Update Submit

May 11, 2009

Conditions

Diabetic Macular Ischemia

Study Arms (3)

Oxygen

EXPERIMENTAL
Other: oxygen

Enalapril

EXPERIMENTAL
Drug: enalapril

Control

PLACEBO COMPARATOR
Drug: placebo

Interventions

enalaprilDRUG

enalapril 5 mg every night

Enalapril
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

Oxygen
placeboDRUG
Control

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with diabetic macular ischemia

You may not qualify if:

  • HTN \> 1140/90 or HTN controlled by ACE inhibitors
  • FBS \> 200
  • Severe anemia, COPD, cataract, HRPDR and diffuse macular edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Tehran Province, 166666, Iran

RECRUITING

MeSH Terms

Interventions

EnalaprilOxygen

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsChalcogensElementsInorganic ChemicalsGases

Central Study Contacts

Masoud Soheilian, MD

CONTACT

+982122585952labbafi@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 12, 2009

Last Updated

May 12, 2009

Record last verified: 2009-05

Locations

IR(1)