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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ophthalmic Consultants of Boston
• Collaborator: Bausch & Lomb Incorporated
• Treatments: Bromfenac; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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