NCT03384524

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

A Phase I/II Evaluation of Bromocriptine, Metoprolol and Tamsulosin Combination Therapy in Eyes With Non-Central Diabetic Macular Edema

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Andrew Moshfeghi, MD, MBA · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2017-12-27
• Last updated: 2019-04-01