Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT00548158
Status:
COMPLETED
Last Update Posted:
2007-10-23
First Post:
2007-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pioglitazone Therapy for Type 2 Diabetes on Vision
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Preliminary Safety Study of Pioglitazone Therapy for Diabetes on Macular Thickness and Vision in Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We are studying patients with diabetes who under proper medical care and administer an approved drug. Our interest is if this drug has any sideeffect on vision and if this drug may cause swelling of the retina.
Detailed Description:
To evaluate the safety of pioglitazone treatment for diabetes. Recent reports suggest that oral glitazone treatment may cause or exacerbate retinal edema. We hypothesized that glitazone treatment may cause subclinical edema evidenced by increased retinal thickness. We will conduct a double-masked, prospective safety study of 19 subjects undergoing placebo-controlled treatment with pioglitazone. Patient treatment consisted of either insulin with placebo or insulin with pioglitazone. The main outcome measures are ETDRS visual acuity and retinal thickness measured with optical coherence tomography.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: