Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-03-11 @ 10:29 PM
Study NCT ID:
NCT00491166
Status:
UNKNOWN
Last Update Posted:
2007-06-25
First Post:
2007-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser
Sponsor:
Ophthalmic Consultants of Boston
Organization:
Study Overview
Official Title:
A Single-Center, Investigator-Sponsored Pilot Study to Assess Safety and Biologic Activity of Bromfenac Ophthalmic Solution, 0.09%, in Subjects With Diffuse DME Refractory to Laser
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
RECRUITING
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:
This is an investigator-sponsored trial (IST), an open-label pilot study, assessing the safety and biologic activity of bromfenac in subjects with diffuse DME refractory to laser.
Detailed Description:
Ten subjects will be enrolled in this study, which will be conducted at Ophthalmic Consultants of Boston, Boston, MA. All subjects must be diagnosed with diffuse DME that is either refractory to laser photocoagulation or in patients who have refused laser.
Consented subjects will be screened to determine eligibility. Eligibility will be determined by the Investigator, a retinal specialist. Only one eye will be chosen as the "study eye." Only the study eye will receive bromfenac drops during the study.
Eligible subjects will self-administer bromfenac two times per day (BID) for three months (treatment period). Subjects will have monthly examinations during the treatment period, followed by follow up visits at Month 4 and Month 6.
Consented subjects will be screened to determine eligibility. Eligibility will be determined by the Investigator, a retinal specialist. Only one eye will be chosen as the "study eye." Only the study eye will receive bromfenac drops during the study.
Eligible subjects will self-administer bromfenac two times per day (BID) for three months (treatment period). Subjects will have monthly examinations during the treatment period, followed by follow up visits at Month 4 and Month 6.
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?: