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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491166
Recruitment Status : Unknown
Verified June 2007 by Ophthalmic Consultants of Boston.
Recruitment status was:  Recruiting
First Posted : June 25, 2007
Last Update Posted : June 25, 2007
Bausch & Lomb Incorporated
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Bromfenac ophthalmic solution Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Primary Outcome Measures :
  1. 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. [ Time Frame: Baseline to month 3 ]

Secondary Outcome Measures :
  1. Changes in retinal leakage as determined by fluorescein angiography [ Time Frame: Baseline to month 3 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00491166

United States, Massachusetts
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeffrey S Heier, MD    617-314-2611      
Contact: Sandy G Chong    617-314-2627   
Principal Investigator: Jeffrey S Heier, MD         
Sponsors and Collaborators
Ophthalmic Consultants of Boston
Bausch & Lomb Incorporated
Principal Investigator: Jeffrey S Heier, MD Ophthalmic Consultants of Boston Identifier: NCT00491166     History of Changes
Other Study ID Numbers: X-DME-001
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: June 25, 2007
Last Verified: June 2007

Keywords provided by Ophthalmic Consultants of Boston:
diabetic macular edema
bromfenac ophthalmic solution

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents