Evaluation of the Effects of Oxygen Therapy and Enalapril for Diabetic Macular Ischemia

This study is currently recruiting participants.

Verified by Shaheed Beheshti Medical University, May 2009

First Received: May 11, 2009 No Changes Posted

Sponsored by:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00899587

Purpose

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.

Condition	Intervention	Phase
Diabetic Macular Ischemia	Drug: enalapril Other: oxygen Drug: placebo	Phase I

Study Type:	Interventional
Official Title:	Evaluation of the Effects of Oxygen Therapy and Enalapril for Diabetic Macular Ischemia

Resource links provided by NLM:

Drug Information available for: Enalapril Enalapril maleate Enalaprilat

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Arms	Assigned Interventions
Oxygen: Experimental	Other: oxygen 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
Enalapril: Experimental	Drug: enalapril enalapril 5 mg every night
Control: Placebo Comparator	Drug: placebo

Eligibility

Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Patients diagnosed with diabetic macular ischemia

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899587

Contacts

Contact: Masoud Soheilian, MD

+982122585952

labbafi@hotmail.com

Locations

Iran, Islamic Republic of
Ophthalmic Research Center	Recruiting
Tehran, Iran, Islamic Republic of, 166666
Contact: Masoud Soheilian, MD +98 21 22585952 labbafi@hotmail.com

Sponsors and Collaborators

Shaheed Beheshti Medical University

More Information

No publications provided

Study ID Numbers:	8753
Study First Received:	May 11, 2009
Last Updated:	May 11, 2009
ClinicalTrials.gov Identifier:	NCT00899587 History of Changes
Health Authority:	Iran: Ethics Committee

Study placed in the following topic categories:

Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Agents

Ischemia
Antihypertensive Agents
Protease Inhibitors

Additional relevant MeSH terms:

Enalapril
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Enalaprilat
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors

Enzyme Inhibitors
Cardiovascular Agents
Ischemia
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on September 11, 2009