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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Ophthalmic Consultants of Boston.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier:
NCT00491166
First received: June 21, 2007
Last updated: June 22, 2007
Last verified: June 2007
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Jeffrey S Heier, MD Ophthalmic Consultants of Boston
  More Information

No publications provided

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

Keywords provided by Ophthalmic Consultants of Boston:
diabetic macular edema
bromfenac ophthalmic solution

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Bromfenac
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 29, 2014