Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Drug: Bromfenac ophthalmic solution||Phase 1|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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 ]
- Changes in retinal leakage as determined by fluorescein angiography [ Time Frame: Baseline to month 3 ]
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 ClinicalTrials.gov 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 firstname.lastname@example.org|
|Principal Investigator: Jeffrey S Heier, MD|
|Principal Investigator:||Jeffrey S Heier, MD||Ophthalmic Consultants of Boston|