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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00491166
• Other study ID #: X-DME-001
• Status: Recruiting
• Phase: Phase 1
• First received: June 21, 2007
• Last updated: June 22, 2007
• Start date: June 2007

Study information

• Verified date: June 2007
• Source: Ophthalmic Consultants of Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Bromfenac ophthalmic solution

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Ophthalmic Consultants of Boston	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in retinal leakage as determined by fluorescein angiography		Baseline to month 3