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

This study is currently recruiting participants.

Verified by Ophthalmic Consultants of Boston, June 2007

First Received: June 21, 2007 Last Updated: June 22, 2007 History of Changes

Sponsors and Collaborators:	Ophthalmic Consultants of Boston ISTA Pharmaceuticals
Information provided by:	Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier:	NCT00491166

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 I

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Bromfenac Bromfenac sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Ophthalmic Consultants of Boston:

Primary Outcome Measures:

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:

Changes in retinal leakage as determined by fluorescein angiography [ Time Frame: Baseline to month 3 ]

Estimated Enrollment:	10
Study Start Date:	June 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491166

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

Sponsors and Collaborators

Ophthalmic Consultants of Boston

ISTA Pharmaceuticals

Investigators

Principal Investigator:

Jeffrey S Heier, MD

Ophthalmic Consultants of Boston

More Information

No publications provided

Study ID Numbers:	X-DME-001
Study First Received:	June 21, 2007
Last Updated:	June 22, 2007
ClinicalTrials.gov Identifier:	NCT00491166 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ophthalmic Consultants of Boston:

diabetic macular edema
bromfenac ophthalmic solution

Study placed in the following topic categories:

Anti-Inflammatory Agents
Eye Diseases
Edema
Macular Degeneration
Retinal Degeneration
Macular Edema
Signs and Symptoms

Bromfenac
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Retinal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Eye Diseases
Physiological Effects of Drugs
Edema
Macular Degeneration
Retinal Degeneration
Pharmacologic Actions
Macular Edema
Signs and Symptoms
Bromfenac

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009