Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema. - Full Text View

Sponsor:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00438243

Purpose

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.

Condition	Intervention	Phase
Cystoid Macular Edema	Drug: Bromfenac (Xibrom) Drug: Refresh Plus	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema.

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Bromfenac Bromfenac sodium

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 1 drop affected eye twice daily.	Drug: Refresh Plus 1 drop in the affected eye twice daily
Experimental: 2 Bromfenac (Xibrom) 1 drop to affected eye twice a day.	Drug: Bromfenac (Xibrom) 1 drop to affected eye twice daily.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438243

Locations

United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Alisa Kim, MD

The Johns Hopkins University School of Medicine

More Information

No publications provided

Responsible Party:	Alisa Kim, M.D., Johns Hopkins University/ The Wilmer Eye Institute
ClinicalTrials.gov Identifier:	NCT00438243 History of Changes
Other Study ID Numbers:	8377
Study First Received:	February 21, 2007
Last Updated:	May 14, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

Pseudophakic macular edema

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 13, 2012