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

NCT03384524 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2019-04-01

No results posted yet for this study

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

Interventions

DRUG

Bromocriptine 2.5 MG

Administered daily

DRUG

Metoprolol 25 MG

Administered daily

DRUG

Tamsulosin 0.4 MG

Administered daily

OTHER

Placebo

Three pills, matching active drugs to be administered daily

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • Andrew Moshfeghi, MD, MBA

    lead OTHER

Principal Investigators

  • Andrew A. Moshfeghi, MD, MBA · Associate Professor of Ophthalmology; Director of Vitreoretinal Surgery and Medical Retina Fellowship; Director of Clinical Trials Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2019-05-31
Completion
2019-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03384524 on ClinicalTrials.gov