drugset / Trial / NCT03384524

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

NCT03384524

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bromocriptine Small molecule 2.5 mg
Comparator Metoprolol Other / unclassified 25 mg
Comparator Tamsulosin Other / unclassified 0.4 mg