Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diabetic Macular Edema |
Drug: Bromfenac ophthalmic solution |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- 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 ]
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 schong@eyeboston.com | |
| Principal Investigator: Jeffrey S Heier, MD | |
| Principal Investigator: | Jeffrey S Heier, MD | Ophthalmic Consultants of Boston |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00491166 History of Changes |
| Other Study ID Numbers: | X-DME-001 |
| Study First Received: | June 21, 2007 |
| Last Updated: | June 22, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ophthalmic Consultants of Boston:
|
diabetic macular edema bromfenac ophthalmic solution |
Additional relevant MeSH terms:
|
Edema Macular Edema Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Bromfenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013