Phase II study of Efficacy and Safety of SJE-2079 in the Treatment for Diabetic Macular Edema
Not Applicable
- Conditions
- Diabetic macular edema (DME)
- Registration Number
- JPRN-UMIN000005648
- Lead Sponsor
- Clinical Development Div., Senju Pharmaceutical co.,ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method