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

NCT ID: NCT00491166

Last Updated: 2007-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Brief Summary

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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

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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.

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bromfenac ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role collaborator

Ophthalmic Consultants of Boston

OTHER

Sponsor Role lead

Principal Investigators

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Jeffrey S Heier, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Boston

Locations

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Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Jeffrey S Heier, MD

Role: primary

617-314-2611

Sandy G Chong

Role: backup

[email protected]
617-314-2627

Other Identifiers

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X-DME-001

Identifier Type: -

Identifier Source: org_study_id