Diabetic macular edema (DME)
Conditions
Sponsors
Clinical Development Div., Senju Pharmaceutical co.,ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Diagnosis of type 2 diabetes mellitus 2)Non-proliferative diabetic retinopathy for study eyes 3)Best corrected visual acuity in the efficacy evaluation-intended eye of 30-80 EDTRS letters 4)OCT retinal thickness at center point in the efficacy evaluation-intended eye of >=350 microns
Exclusion criteria
Exclusion criteria: 1)Active and serious retinal disease 2)History of steroid-induced elevation of IOP 3)Any active ocular disease other than diabetic retinopathy 4)HbA1c of >=10.0% 5)Instillation of any corticosteroid, nonsteroidal anti-inflammatory drug or carbonic anhydrase inhibitor within 4 weeks 6)Systemic administration of any corticosteroid within 4 weeks 7)Macular photocoagulation, injection of corticosteroid or any affective drug into the vitreous, sub-tenon capsule and sub-conjunctiva, vitreous surgery, hyperbaric oxygen therapy, stellate ganglion block, cataract surgery or other intraocular surgery within 24 weeks 8)Retinal photocoagulation except macular area within 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in retinal central foveal thickness using optical coherence tomography (OCT) | — |
Countries
Japan
Outcome results
None listed