Evaluation of Bromocriptine, Metoprolol and Tamsulosin in Eyes With Non-Central DME

NCT ID: NCT03384524

Last Updated: 2019-04-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2019-05-31

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Combination regiment

A combination regiment of Bromocriptine (2.5 mg/day), Metoprolol (25 mg/day) and Tamsulosin (0.4 mg/day)

Group Type: ACTIVE_COMPARATOR

Bromocriptine 2.5 MG

Intervention Type: DRUG

Administered daily

Metoprolol 25 MG

Intervention Type: DRUG

Administered daily

Tamsulosin 0.4 MG

Intervention Type: DRUG

Administered daily

Placebo

Three placebo pills, matching the external appearance of active drugs

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Three pills, matching active drugs to be administered daily

Interventions

Bromocriptine 2.5 MG

Administered daily

Intervention Type: DRUG

Metoprolol 25 MG

Administered daily

Intervention Type: DRUG

Tamsulosin 0.4 MG

Administered daily

Intervention Type: DRUG

Placebo

Three pills, matching active drugs to be administered daily

Intervention Type: OTHER

Other Intervention Names

Bromocriptine Mesylate; Metoprolol Tartrate; Tamsulosin HCL; Tamsulosin Hydrochloride

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: collaborator

Andrew Moshfeghi, MD, MBA

OTHER

Sponsor Role: lead

Responsible Party

Andrew Moshfeghi, MD, MBA

Associate Professor of Ophthalmology, Director of Vitreoretinal Surgery Fellowship and Medical Retina Fellowship, Director of Clinical Trials Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrew A. Moshfeghi, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Ophthalmology; Director of Vitreoretinal Surgery and Medical Retina Fellowship; Director of Clinical Trials Unit

Other Identifiers

The BEAT DME Study

Identifier Type: -

Identifier Source: org_study_id