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

June 22, 2007 updated by: Ophthalmic Consultants of Boston

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Ophthalmic Consultants of Boston
        • Contact:
          • Jeffrey S Heier, MD
          • Phone Number: 617-314-2611
        • Contact:
        • Principal Investigator:
          • Jeffrey S Heier, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Baseline to month 3
Baseline to month 3

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ophthalmic Consultants of Boston

Collaborators

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Registration Dates

First Submitted

June 21, 2007

First Submitted That Met QC Criteria

June 22, 2007

First Posted (ESTIMATE)

June 25, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 25, 2007

Last Update Submitted That Met QC Criteria

June 22, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X-DME-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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