Diabetic Macular EdemaPhase 1NCT00491166
Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser
A Phase 1 study testing Bromfenac ophthalmic solution in people with Diabetic Macular Edema, run by Ophthalmic Consultants of Boston at 1 site in United States.
Trial summary
This is an investigator-sponsored trial (IST), an open-label pilot study, assessing the safety and biologic activity of bromfenac in subjects with diffuse DME refractory to laser. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Bromfenac ophthalmic solution
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to not given
- Phase
- Phase 1
- 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
- Age > 18 years
- Center-involved macular edema secondary to diabetes mellitus
Who cannot join
- Study eye with edema amenable to focal laser
- Treatment with laser, intraocular steroids, and anti-VEGF agents within 90 days
- Current eye infections
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Jeffrey S Heier, MD, 617-314-2611
Sandy G Chong, 617-314-2627, schong@eyeboston.com
About this study
Official title: A Single-Center, Investigator-Sponsored Pilot Study to Assess Safety and Biologic Activity of Bromfenac Ophthalmic Solution, 0.09%, in Subjects With Diffuse DME Refractory to Laser
This is an investigator-sponsored trial (IST), an open-label pilot study, assessing the safety and biologic activity of bromfenac in subjects with diffuse DME refractory to laser.
Read the detailed description
Ten subjects will be enrolled in this study, which will be conducted at Ophthalmic Consultants of Boston, Boston, MA. All subjects must be diagnosed with diffuse DME that is either refractory to laser photocoagulation or in patients who have refused laser.
Consented subjects will be screened to determine eligibility. Eligibility will be determined by the Investigator, a retinal specialist. Only one eye will be chosen as the "study eye." Only the study eye will receive bromfenac drops during the study.
Eligible subjects will self-administer bromfenac two times per day (BID) for three months (treatment period). Subjects will have monthly examinations during the treatment period, followed by follow up visits at Month 4 and Month 6.
- Conditions
- Diabetic Macular Edema
- Being tested
- Bromfenac ophthalmic solution
- Keywords
- diabetic macular edema, bromfenac ophthalmic solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromfenac ophthalmic solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in visual acuity and central retinal thickness from baseline to month 3,and the incidence and severity of ocular adverse events and other adverse events.
Measured: Baseline to month 3
Secondary outcomes (1)
Changes in retinal leakage as determined by fluorescein angiography
Measured: Baseline to month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants of Boston
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Investigators
- Jeffrey S Heier, MD, Principal investigator, Ophthalmic Consultants of Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491166
- Sponsor's protocol ID
- X-DME-001
- Status last verified
- Jun 2007
- First submitted
- 21 Jun 2007
- Last updated
- 25 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Investigator-Sponsored Pilot Study to Assess Safety and Biologic Activity of Bromfenac Ophthalmic Solution, 0.09%, in Subjects With Diffuse DME Refractory to Laser
- ClinicalTrials.gov ID
- NCT00491166
- Acronym / sponsor ID
- X-DME-001
- Conditions
- Diabetic Macular Edema
- Keywords
- diabetic macular edema, bromfenac ophthalmic solution
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ophthalmic Consultants of BostonUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Jun 2007
- First posted
- 25 Jun 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 is an investigator-sponsored trial (IST), an open-label pilot study, assessing the safety and biologic activity of bromfenac in subjects with diffuse DME refractory to laser.
Detailed description
Ten subjects will be enrolled in this study, which will be conducted at Ophthalmic Consultants of Boston, Boston, MA. All subjects must be diagnosed with diffuse DME that is either refractory to laser photocoagulation or in patients who have refused laser.
Consented subjects will be screened to determine eligibility. Eligibility will be determined by the Investigator, a retinal specialist. Only one eye will be chosen as the "study eye." Only the study eye will receive bromfenac drops during the study.
Eligible subjects will self-administer bromfenac two times per day (BID) for three months (treatment period). Subjects will have monthly examinations during the treatment period, followed by follow up visits at Month 4 and Month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Center-involved macular edema secondary to diabetes mellitus
Key exclusion criteria (3 listed)
- Study eye with edema amenable to focal laser
- Treatment with laser, intraocular steroids, and anti-VEGF agents within 90 days
- Current eye infections
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 ophthalmic solution | Drug | – |
Primary outcome
The mean change in visual acuity and central retinal thickness from baseline to month 3,and the incidence and severity of ocular adverse events and other adverse events.
Time frame: Baseline to month 3
1 secondary outcome
Changes in retinal leakage as determined by fluorescein angiography
Time frame: Baseline to month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2007.
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
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.
Jeffrey S Heier, MD principal investigator
Ophthalmic Consultants of Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bromfenac ophthalmic solution in people with Diabetic Macular Edema, run by Ophthalmic Consultants of Boston 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jun 2007. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in visual acuity and central retinal thickness from baseline to month 3,and the incidence and severity of ocular adverse events and other adverse events. (time frame: Baseline to month 3). 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 25 Jun 2007.