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Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema.
This study is ongoing, but not recruiting participants.
Study NCT00438243   Information provided by Johns Hopkins University
First Received: February 21, 2007   Last Updated: May 14, 2008   History of Changes

February 21, 2007
May 14, 2008
May 2008
July 2010   (final data collection date for primary outcome measure)
Proportion of subjects improving >/= 10 letter (2 lines) of best-corrected distance visual acuity at day 90 ± 14 days after initiation of one of the test agents. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of subjects improving >/= 10 letter (2 lines) of best-corrected distance visual acuity at day 90 ± 14 days after initiation of one of the test agents.
Complete list of historical versions of study NCT00438243 on ClinicalTrials.gov Archive Site
  • Analysis of the decrease in the center point retinal thickness by OCT at 90 ± 14 days after initiation of the test agent. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Analysis of patient comfort during the use of test agent as assessed with the ocular comfort grading scale [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Analysis of the decrease in the center point retinal thickness by OCT at 90 ± 14 days after initiation of the test agent.
  • Analysis of patient comfort during the use of test agent as assessed with the ocular comfort grading scale
 
Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema.
Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema.

This research is being done to look at the effects of Bromfenac, also called Xibrom for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) called "macular edema" that occurs after cataract surgery. Swelling in the retina can lead to blurry vision.

The most commonly used treatment is eyedrops that decrease inflammation and may help stop some of the swelling. We want to see if the drug Bromfenac(Xibrom) can decrease the swelling in the retina after cataract surgery and improve vision in these patients.

Over 2.5 million cataract surgeries are performed yearly in the United States. Despite advances in cataract surgery, cystoid macular edema (CME) is the most common cause of loss of vision after cataract surgery, occurring in approximately 0.3% to 3% of all uncomplicated surgeries. If the surgery is complicated, CME can occur in up to 20% of these patients. In CME, fluid accumulates in cystic spaces within the outer plexiform layer of the retina, resulting in decreased vision.

Ocular nonsteroidal anti-inflammatory drugs (NSAIDs) have been widely used in the treatment of CME. NSAIDs decrease inflammation and are hypothesized to decrease the production of prostaglandins via selective inhibition of the cyclooxygenase pathway, which can result in CME. The standard of care for management of postoperative pseudophakic macular edema to some extent remains unclear. There is currently no FDA-approved therapy for the prophylaxis or treatment of postoperative cystoid macular edema.

Bromfenac (Xibrom)an NSAID and is FDA-approved for ocular use to treat pain and inflammation after ocular surgery. Therefore, these medications might decrease inflammation and be effective in treating CME. We plan to conduct a controlled study to investigate the effect of Bromfenac (Xibrom)in patients who develop CME after cataract surgery. The results of this study may be important in better understanding the pathogenesis and treatment of acute postoperative cystoid macular edema to prevent chronic vision loss.

Phase II
Interventional
Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Cystoid Macular Edema
  • Drug: Bromfenac (Xibrom)
  • Drug: Refresh Plus
  • Placebo Comparator: 1 drop affected eye twice daily.
  • Experimental: Bromfenac (Xibrom) 1 drop to affected eye twice a day.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
100
September 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults (ages 18 years or older)
  • Best-corrected visual acuity 20/40 or worse
  • Pseudophakic CME in the study eye with onset at least three weeks and no more than four months after cataract surgery, as document on fluorescein angiography and/or OCT (central subfield >/= 250 microns)
  • Agree to avoid disallowed medications (including ocular, topical, or systemic NSAIDs; ocular, topical, or systemic corticosteroids; ocular prostaglandin analogs) throughout the duration of the study. Agree to a 14 day washout period prior to enrollment if currently using a disallowed medication.

Exclusion Criteria:

  • History of a known hypersensitivity to bromfenac, or any component of the test agents and/or "procedural" medications (such as anesthetic, dilating drops, fluorescein, etc)
  • History of pre-existing macular disease that confounds and/or precludes the evaluation of cystoid macular edema (including but not limited to macular hole, epiretinal membrane with pseudohole, diabetic macular edema, neovascular age-related macular degeneration, acute posterior uveitis)
  • CME due to other etiologies such as vein occlusion
  • Use of a topical ophthalmic prostaglandin analog within 14 days prior to enrollment, i.e., the subject does not agree to a 14 day washout period prior to enrollment.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438243
Alisa Kim, M.D., Johns Hopkins University/ The Wilmer Eye Institute
8377
Johns Hopkins University
 
Principal Investigator: Alisa Kim, MD The Johns Hopkins University School of Medicine
Johns Hopkins University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP