Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema.
Recruitment status was Active, not recruiting
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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 2 |
| 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. |
- 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 ]
- 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 |
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| United States, Maryland | |
| The Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| 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 May 16, 2013