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Darapladib in diabetic macular edema
NL-OMON35596Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Aug 2012
- Countries
- 1
- Sponsor
- GSK
- Modality
- Small Molecules
- Drugs
- darapladib
- Conditions
- diabetic macular edema (DME)
01
Overview
Phase 2, randomised, double-blind trial in diabetic macular edema (DME) comparing Darapladib with Placebo (2 arms). Primary endpoints: Best-corrected visual acuity in the study eye and SD-OCT center subfield retinal thickness in the study eye. Started Aug 2012; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Darapladib
Oral darapladib administered for 3 months.
Placebo
Matching oral placebo administered for 3 months.
03
Who it enrols
Adults with center-involved diabetic macular edema confirmed by fluorescein angiography, with retinal thickening and reduced best-corrected visual acuity, and either type 1 or type 2 diabetes mellitus. Major exclusions included other ocular diseases interfering with assessment, active proliferative diabetic retinopathy, ischemic maculopathy, recent ocular procedures or intravitreal therapy, poor diabetes control, pregnancy or breastfeeding, severe uncontrolled asthma, and use of strong CYP3A4 inhibitors or certain restricted prior medications.
04
Endpoints
Primary
Best-corrected visual acuity in the study eye
SD-OCT center subfield retinal thickness in the study eye
Secondary
Changes in retinal anatomy of the study eye
Safety and tolerability
Pharmacokinetics
Pharmacodynamics
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