Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser

Phase 1

• Conditions: Diabetic Macular Edema

• Registration Number: NCT00491166
• Lead Sponsor: Ophthalmic Consultants of Boston

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.

Study Timeline

• Status Verified: 2007-06
• Study Start: 2007-06
• Study First Submitted: 2007-06-21
• Study First Submitted QC: 2007-06-22
• Last Update Submitted: 2007-06-22
• Study First Posted: 2007-06-25
• Last Update Posted: 2007-06-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age > 18 years
• Center-involved macular edema secondary to diabetes mellitus

Exclusion Criteria

• Study eye with edema amenable to focal laser
• Treatment with laser, intraocular steroids, and anti-VEGF agents within 90 days
• Current eye infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The mean change in visual acuity and central retinal thickness from baseline to month 3,and the incidence and severity of ocular adverse events and other adverse events.	Baseline to month 3

Secondary Outcome Measures

Name	Time	Method
Changes in retinal leakage as determined by fluorescein angiography	Baseline to month 3

Trial Locations

Locations (1)

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States