Cystoid Macular EdemaPhase 2NCT00438243
Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-operative Cystoid Macular Edema.
A Phase 2 study testing Bromfenac (Xibrom) and Refresh Plus in people with Cystoid Macular Edema, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystoid Macular Edema
- What is being tested?
- Bromfenac (Xibrom) and Refresh Plus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
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.
Read the 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. 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.
- Conditions
- Cystoid Macular Edema
- Being tested
- Bromfenac (Xibrom), Refresh Plus
- Keywords
- Pseudophakic macular edema
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromfenac (Xibrom)Drug
1 drop to affected eye twice daily.
Refresh PlusDrug
1 drop in the affected eye twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 1 drop affected eye twice daily. Receives: Drug: Refresh Plus |
| 2 | Experimental | Bromfenac (Xibrom) 1 drop to affected eye twice a day. Receives: Drug: Bromfenac (Xibrom) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
Analysis of patient comfort during the use of test agent as assessed with the ocular comfort grading scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startMay 2008
- Primary completionJul 2010
- Study completionSep 2010
Why it stopped: Principal Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystoid Macular EdemaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alisa Kim, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438243
- Sponsor's protocol ID
- 8377
- Status last verified
- Jul 2016
- First submitted
- 21 Feb 2007
- Last updated
- 4 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-operative Cystoid Macular Edema.
- ClinicalTrials.gov ID
- NCT00438243
- Acronym / sponsor ID
- 8377
- Conditions
- Cystoid Macular Edema
- Keywords
- Pseudophakic macular edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Refresh Plus1 drop affected eye twice daily. |
| 2 | Experimental | Drug: Bromfenac (Xibrom)Bromfenac (Xibrom) 1 drop to affected eye twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bromfenac (Xibrom)1 drop to affected eye twice daily. | Drug | 2 |
| Refresh Plus1 drop in the affected eye twice daily | Drug | 1 |
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.
Time frame: 6 months
2 secondary outcomes
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.
Time frame: 6 months
Analysis of patient comfort during the use of test agent as assessed with the ocular comfort grading scale
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alisa Kim, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bromfenac (Xibrom) and Refresh Plus in people with Cystoid Macular Edema, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.