Diabetic Macular EdemaPhase 1/2NCT03384524
Evaluation of Bromocriptine, Metoprolol and Tamsulosin in Eyes With Non-Central DME
A Phase 1/2 study testing Bromocriptine 2.5 MG, Metoprolol 25 MG and Tamsulosin 0.4 MG in people with Diabetic Macular Edema, run by Andrew Moshfeghi, MD, MBA.
Trial summary
This phase I/II trial is designed to provide proof of concept evidence that combination therapy can have a beneficial effect on DME and possibly prevent increases in retinal volume or progression of non-central DME into the central subfield of the macula. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Bromocriptine 2.5 MG, Metoprolol 25 MG and Tamsulosin 0.4 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to May 2019
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Type 1 or type 2 diabetes mellitus
- Best corrected visual acuity using the early treatment diabetic retinopathy study (ETDRS) visual acuity test letter score ≥ 74 (i.e., 20/32 or better) within 30 days of enrollment.
- On clinical exam, definite retinal thickening due to DME within 3,000 μm of the center of the macula but not involving the 500 μm central subfield.
- Thickened non-central macular subfields on the spectral domain OCT macular map
- Central subfield thickness within threshold definition for normal central subfield thickness
- No focal/grid laser within the last 6 months or other treatment for DME within the last 4 months.
- Pseudophakia
Who cannot join
- Patients with active proliferative diabetic retinopathy
- Pan retinal photocoagulation within the last 12 months of study initiation
- A condition that, in the opinion of the investigator, would preclude participation in the study, e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control.
- Subjects experiencing poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months.
- Use of systemic corticosteroids or anti-VEGF (vascular endothelial growth factor) therapy.
- Participation in an investigational trial that involves treatment with any drug within 30 days of randomization that has not received regulatory approval at the time of study entry.
Show all 17Show fewer
- Note: study participants cannot receive another investigational drug while participating in this study.
- Known allergy or hypersensitivity to any component of the study drugs.
- Postpartum women with a history of coronary artery disease or other severe cardiovascular conditions (a bromocriptine contraindication).
- Planned glaucoma surgery (floppy iris syndrome associated with tamsulosin therapy).
- Blood pressure > 180/110 mmHg (systolic above 180 or diastolic above 110 mmHg).
- If blood pressure is brought below 180/110 by anti-hypertensive treatment, an individual can become eligible.
- Subjects with second or third degree heart block (metoprolol contraindication).
- Subjects with asthma or other bronchospastic disease (metoprolol precaution).
- Individuals currently taking one of the study medications or a medication in the same therapeutic class (beta receptor antagonists, alpha-1 receptor antagonists, or bromocriptine).
- Participants expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 12 months of the study.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months. Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment will be used to determine when a pregnancy test is needed.
About this study
Official title: A Phase I/II Evaluation of Bromocriptine, Metoprolol and Tamsulosin Combination Therapy in Eyes With Non-Central Diabetic Macular Edema
This phase I/II trial is designed to provide proof of concept evidence that combination therapy can have a beneficial effect on DME and possibly prevent increases in retinal volume or progression of non-central DME into the central subfield of the macula. If a beneficial effect is apparent in this phase I/II study involving a relatively small sample size and short follow-up period, its results could be used to in plan future phase III trials. We believe this study will be the first to show that a systems pharmacology approach can successfully address diabetic macular edema, and thus revolutionize the treatment of complex retinal diseases for which there are a paucity of effective treatment options.
- Conditions
- Diabetic Macular Edema
- Being tested
- Bromocriptine 2.5 MG, Metoprolol 25 MG, Tamsulosin 0.4 MG, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromocriptine 2.5 MGDrug
Also called Bromocriptine Mesylate
Administered daily
Metoprolol 25 MGDrug
Also called Metoprolol Tartrate
Administered daily
Tamsulosin 0.4 MGDrug
Also called Tamsulosin HCL, Tamsulosin Hydrochloride
Administered daily
PlaceboOther
Three pills, matching active drugs to be administered daily
| Study group | Role | What they receive |
|---|---|---|
| Combination regiment | Active comparator | A combination regiment of Bromocriptine (2.5 mg/day), Metoprolol (25 mg/day) and Tamsulosin (0.4 mg/day) Receives: Drug: Bromocriptine 2.5 MG; Drug: Metoprolol 25 MG; Drug: Tamsulosin 0.4 MG |
| Placebo | Placebo comparator | Three placebo pills, matching the external appearance of active drugs Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in retinal volume
Effects of bromocriptine/metoprolol/tamsulosin combination therapy on macular retinal volume compared with placebo in eyes with non-central diabetic macular edema (DME)
Measured: 14 months
Secondary outcomes (4)
Progression of non-central DME compared to central DME
Effects of therapy with bromocriptine/metoprolol/tamsulosin on central subfield thickness and compare the progression of non-central DME to central DME as determined by stereoscopic fundus photographs.
Measured: 14 months
Progression of non-central DME compared to central DME
Effects of therapy with bromocriptine/metoprolol/tamsulosin on central subfield thickness and compare the progression of non-central DME to central DME as determined by Optical Coherence Tomography (OCT).
Measured: 14 months
Change in retinal density
Measured by OCT-angiography
Measured: 14 months
Foveal avascular changes
Measured by fluorescein angiography.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study startMar 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Why it stopped: withdrawn during planning stages
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Moshfeghi, MD, MBA
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Sponsor-investigator, Andrew Moshfeghi, MD, MBA, University of Southern California
- Investigators
- Andrew A. Moshfeghi, MD, MBA, Principal investigator, Associate Professor of Ophthalmology; Director of Vitreoretinal Surgery and Medical Retina Fellowship; Director of Clinical Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384524
- Sponsor's protocol ID
- The BEAT DME Study
- Status last verified
- Mar 2019
- First submitted
- 15 Dec 2017
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Evaluation of Bromocriptine, Metoprolol and Tamsulosin Combination Therapy in Eyes With Non-Central Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03384524
- Acronym / sponsor ID
- The BEAT DME Study
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn during planning stages
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Andrew Moshfeghi, MD, MBAUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- Mar 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 27 Dec 2017 (actual)
- 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 phase I/II trial is designed to provide proof of concept evidence that combination therapy can have a beneficial effect on DME and possibly prevent increases in retinal volume or progression of non-central DME into the central subfield of the macula. If a beneficial effect is apparent in this phase I/II study involving a relatively small sample size and short follow-up period, its results could be used to in plan future phase III trials. We believe this study will be the first to show that a systems pharmacology approach can successfully address diabetic macular edema, and thus revolutionize the treatment of complex retinal diseases for which there are a paucity of effective treatment options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination regiment | Active comparator | Drug: Bromocriptine 2.5 MG, Drug: Metoprolol 25 MG, Drug: Tamsulosin 0.4 MGA combination regiment of Bromocriptine (2.5 mg/day), Metoprolol (25 mg/day) and Tamsulosin (0.4 mg/day) |
| Placebo | Placebo comparator | Other: PlaceboThree placebo pills, matching the external appearance of active drugs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 years
- Type 1 or type 2 diabetes mellitus
- Best corrected visual acuity using the early treatment diabetic retinopathy study (ETDRS) visual acuity test letter score ≥ 74 (i.e., 20/32 or better) within 30 days of enrollment.
- On clinical exam, definite retinal thickening due to DME within 3,000 μm of the center of the macula but not involving the 500 μm central subfield.
- Thickened non-central macular subfields on the spectral domain OCT macular map
Key exclusion criteria (17 listed)
- Patients with active proliferative diabetic retinopathy
- Pan retinal photocoagulation within the last 12 months of study initiation
- A condition that, in the opinion of the investigator, would preclude participation in the study, e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control.
- Subjects experiencing poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months.
- Use of systemic corticosteroids or anti-VEGF (vascular endothelial growth factor) therapy.
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 |
|---|---|---|
| Bromocriptine 2.5 MGAlso: Bromocriptine MesylateAdministered daily | Drug | Combination regiment |
| Metoprolol 25 MGAlso: Metoprolol TartrateAdministered daily | Drug | Combination regiment |
| Tamsulosin 0.4 MGAlso: Tamsulosin HCL, Tamsulosin HydrochlorideAdministered daily | Drug | Combination regiment |
| PlaceboThree pills, matching active drugs to be administered daily | Other | Placebo |
Primary outcome
Change in retinal volume
Time frame: 14 months
Effects of bromocriptine/metoprolol/tamsulosin combination therapy on macular retinal volume compared with placebo in eyes with non-central diabetic macular edema (DME)
4 secondary outcomes
Progression of non-central DME compared to central DME
Time frame: 14 months
Progression of non-central DME compared to central DME
Time frame: 14 months
Change in retinal density
Time frame: 14 months
Foveal avascular changes
Time frame: 14 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 1 Apr 2019.
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
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
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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.
Andrew A. Moshfeghi, MD, MBA principal investigator
Associate Professor of Ophthalmology; Director of Vitreoretinal Surgery and Medical Retina Fellowship; Director of Clinical Trials Unit
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bromocriptine 2.5 MG, Metoprolol 25 MG and Tamsulosin 0.4 MG in people with Diabetic Macular Edema, run by Andrew Moshfeghi, MD, MBA.
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 8 inclusion and 17 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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?
Change in retinal volume (time frame: 14 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 1 Apr 2019.