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

Cystoid Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00438243
• Other study ID #: 8377
• Status: Withdrawn
• Phase: Phase 2
• First received: February 21, 2007
• Last updated: July 1, 2016
• Start date: May 2008
• Est. completion date: September 2010

Study information

• Verified date: July 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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. The investigators want to see if the drug Bromfenac(Xibrom) can decrease the swelling in the retina after cataract surgery and improve vision in these patients.

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. The investigators 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Cystoid Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Bromfenac (Xibrom)
1 drop to affected eye twice daily.
• Refresh Plus
1 drop in the affected eye twice daily

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	No
Secondary	Analysis of the decrease in the center point retinal thickness by Optical Coherence Tomography (OCT) at 90 ± 14 days after initiation of the test agent.		6 months	No
Secondary	Analysis of patient comfort during the use of test agent as assessed with the ocular comfort grading scale		6 months	Yes