Status:
COMPLETED
Ranibizumab vs Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema
Lead Sponsor:
Far Eastern Memorial Hospital
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Vitrectomy is required for removal of vitreous hemorrhage or retinal traction tissue in some patients with proliferative diabetic retinopathy. Post-vitrectomy macular edema may occur in these diabetic...
Detailed Description
Vitrectomy is required for removal of vitreous hemorrhage or retinal traction tissue in some patients with proliferative diabetic retinopathy. Post-vitrectomy macular edema may occur in these diabetic...
Eligibility Criteria
Inclusion
- Age more than 18 years
- Glycosylated hemoglobin (HbA1c) less than 10.0%
- Best-corrected visual acuity (BCVA) between 20/400 to 20/40
- Central foveal thickness (CFT) more than 300 μm in the 1-mm central macular subfield on spectral domain optical coherence tomography (SD-OCT, CIRRUS™ HD-OCT 5000, Carl Zeiss Meditec Inc., Dublin, CA, USA) using 6 radial line scans through the fovea
- Macular leakage on fundus fluorescein angiography (HRA2, Heidelberg Engineering GmbH, Germany)
- The DME pattern can include submacular fluid, cystoid change, and diffuse macular thickening
- All have proliferative diabetic retinopathy treated by panretinal photocoagulation receiving prior vitrectomy without silicone oil or gas inside the vitreous cavity
- Prior intraocular surgery performed as least 3 months ago
Exclusion
- Pregnant or nursing women
- The patients with the history of thromboembolic events or major surgery within the previous 3 months
- Presence of anterior chamber intraocular lens or subluxated/dislocated posterior chamber intraocular lens
- Presence of uncontrolled hypertension
- Known coagulation abnormalities or current use of anticoagulative medication other than aspirin
- Prior macular photocoagulation or photodynamic therapy
- Presence of active infectious disease or intraocular inflammation
- Intraocular pressure more than 20 mmHg or glaucoma history
- Presence of iris neovascularization/vitreous hemorrhage.
- The DME pattern with accompanying macular traction by epiretinal membrane or posterior hyaloid
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04089605
Start Date
June 1 2017
End Date
April 30 2019
Last Update
September 13 2019
Active Locations (1)
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1
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 105