Diabetic Macular Edema
Conditions
Keywords
diabetic macular edema, bromfenac ophthalmic solution
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.
Interventions
Sponsors
Bausch & Lomb Incorporated
Ophthalmic Consultants of Boston
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Changes in retinal leakage as determined by fluorescein angiography | Baseline to month 3 |
Countries
United States
Outcome results
None listed