NCT00491166

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
Last Updated

June 25, 2007

Status Verified

June 1, 2007

First QC Date

June 21, 2007

Last Update Submit

June 22, 2007

Conditions

Diabetic Macular Edema

Keywords

diabetic macular edemabromfenac ophthalmic solution

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to month 3

Secondary Outcomes (1)

  • Changes in retinal leakage as determined by fluorescein angiography

    Baseline to month 3

Interventions

Bromfenac ophthalmic solutionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Center-involved macular edema secondary to diabetes mellitus

You may not qualify if:

  • Study eye with edema amenable to focal laser
  • Treatment with laser, intraocular steroids, and anti-VEGF agents within 90 days
  • Current eye infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

RECRUITING

Study Officials

  • Jeffrey S Heier, MD

    Ophthalmic Consultants of Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2007

First Posted

June 25, 2007

Study Start

June 1, 2007

Last Updated

June 25, 2007

Record last verified: 2007-06

Locations

US(1)