Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema.
Information source: Johns Hopkins University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystoid Macular Edema
Intervention: Bromfenac (Xibrom) (Drug); Refresh Plus (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s):
Alisa Kim, MD, Principal Investigator, Affiliation: The Johns Hopkins University School of Medicine
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. 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.
Clinical Details
Official title: Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema.
Study design: Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
The Johns Hopkins Hospital, Baltimore, Maryland 21287, United States
Additional Information
Starting date: May 2008
Ending date: September 2010
Last updated: May 14, 2008
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