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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Ophthalmic Consultants of Boston.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier:
NCT00491166
First received: June 21, 2007
Last updated: June 22, 2007
Last verified: June 2007

June 21, 2007
June 22, 2007
June 2007
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00491166 on ClinicalTrials.gov Archive Site
Changes in retinal leakage as determined by fluorescein angiography [ Time Frame: Baseline to month 3 ]
Same as current
Not Provided
Not Provided
 
Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser
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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Macular Edema
Drug: Bromfenac ophthalmic solution
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Not Provided
Not Provided

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
Both
18 Years and older
Yes
United States
 
NCT00491166
X-DME-001
No
Not Provided
Ophthalmic Consultants of Boston
Bausch & Lomb Incorporated
Principal Investigator: Jeffrey S Heier, MD Ophthalmic Consultants of Boston
Ophthalmic Consultants of Boston
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP