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Nonsteroidal Anti-inflammatory Drug

Bromfenac Eye Drops for Diabetic Macular Edema

Phase 1

Waitlist Available

Led By Jeffrey S Heier, MD

Research Sponsored by Ophthalmic Consultants of Boston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Center-involved macular edema secondary to diabetes mellitus

Age > 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month 3

Awards & highlights

Study Summary

This trial is testing if a drug called bromfenac is safe and works on people with a certain eye condition.

Who is the study for?

This trial is for adults over 18 with a condition called diffuse diabetic macular edema (DME) that hasn't improved after laser treatment. Participants must not have current eye infections or swelling treatable by focal laser, and should not have had treatments like steroids or anti-VEGF agents in the last 90 days.Check my eligibility

What is being tested?

The study is testing the safety and biological effect of an eye drop solution called Bromfenac on people with DME who haven't responded to laser therapy. It's an open-label pilot study, meaning both researchers and participants know what treatment is being given.See study design

What are the potential side effects?

While specific side effects are not listed, as a safety study, it will monitor any adverse reactions from using Bromfenac ophthalmic solution in patients with DME.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have swelling in the center of my retina due to diabetes.

Select...

I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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.

Secondary outcome measures

Changes in retinal leakage as determined by fluorescein angiography

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ophthalmic Consultants of BostonLead Sponsor

5 Previous Clinical Trials

162 Total Patients Enrolled

Bausch & Lomb IncorporatedIndustry Sponsor

251 Previous Clinical Trials

57,409 Total Patients Enrolled

Jeffrey S Heier, MDPrincipal InvestigatorOphthalmic Consultants of Boston

4 Previous Clinical Trials

193 Total Patients Enrolled

Media Library

Bromfenac Ophthalmic Solution (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT00491166 — Phase 1

Diabetic Macular Edema Research Study Groups:

Diabetic Macular Edema Clinical Trial 2023: Bromfenac Ophthalmic Solution Highlights & Side Effects. Trial Name: NCT00491166 — Phase 1

Bromfenac Ophthalmic Solution (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00491166 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks might patients undergo when utilizing this treatment option?

"Due to the limited amount of clinical data supporting safety and efficacy, this treatment has been rated a 1 on our team's scale. This is commensurate with its Phase 1 trial status."

Answered by AI

Is enrollment in this experiment ongoing at present?

"According to the clinicaltrials.gov listings, this trial is not presently recruiting patients. The initial posting was in June 2007 and it has since been updated; however, there are 114 other medical studies currently seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2007. "Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00491166.

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