JPRN-UMIN000016036
Recruiting
Phase 4
Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy
ConditionsDiabetic macular edema
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Diabetic macular edema
- Sponsor
- Kyushu university
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Vitrectomized eye with recurrent or prolonged diabetic macular edema more than 6 months after vitrectomy
- •( more than 300um in central macular thickness measured by OCT retinal map)
- •2\) 0\.2\-1\.2 in best\-corrected logMAR visual acuity
- •3\) Type 1 or Type 2 diabetes mellitus
- •(20 years and older)
- •4\) Vitrectomy was performed for not proliferative diabetic retinopathy but for diabetic macular edema
- •5\) Written informed consent was obtained
Exclusion Criteria
- •1\) Use of any anti VEGF therapy for candidate eyes after vitrectomy
- •2\) Use of any steroid therapy (except for eye drop) for candidate eyes within 3 months prior to initial injection
- •3\) Intraocular,periocular inflammation or infection in candidate eye
- •4\) Allergy history for drug used in this trial
- •5\) Women who are pregnant or breast feeding or who are capable of becoming pregnant
- •6\) Focal, grid laser photocoagulation within 3 months prior to initial injection
- •7\) Proliferative diabetic retinopathy such as vitreous hemorrhage,preretinal hemorrhage,neovascularization, proliferative membrane,tractional retinal detachment
- •8\) Some of optic disc atrophy
- •9\) Cataract that would interfere with required fundus examinations, fundus photographs or OCT
- •10\) Cataract surgery within 6 months prior to initial injection
Outcomes
Primary Outcomes
Not specified
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