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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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)
Time frame: 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 stereoscopic fundus photographs.
Time frame: 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).
Time frame: 14 months
Change in retinal density
Measured by OCT-angiography
Time frame: 14 months
Foveal avascular changes
Measured by fluorescein angiography.
Time frame: 14 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Three pills, matching active drugs to be administered daily