Ranibizumab vs Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema
NCT ID: NCT04089605
Last Updated: 2019-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
48 participants
INTERVENTIONAL
2017-06-01
2019-04-30
Brief Summary
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Detailed Description
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Pseudophakic vitrectomized eyes with treatment-naïve center-involved DME will be enrolled with one eye in each patient. They are randomized into one group receiving IDI every 3 to 4 months, and the other group undergoing IVR using 3 monthly plus treat-and-extend injections all with monthly follow-up for 6 months. Switch of intravitreal drugs or deferred macular laser is not allowed. Primary outcome measures include change in central foveal thickness (CFT) in 1 mm by spectral-domain optic coherence tomography, and best corrected visual acuity (BCVA) at Month 6. Primary outcome measures include change in CFT and BCVA at Month 6. Injection number, BCVA, CFT, post-injection complications, and IOP are recorded and compared with Wilcoxon signed rank test within the group and Wilcoxon rank sum test between groups. Fisher's exact test is used for categorical comparison between groups. P value less than 0.05 is considered significant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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intravitreal dexamethasone implant
The eyes undergo dexamethasone intravitreal implant 0.7 mg injections at baseline and every 3 or 4 months thereafter. Dexamethasone implants are re-injected in minimal 3-month interval if macular edema persisted or recurred with CFT more than 350 μm or manifestation of apparent submacular fluid and/or intramacular cysts. If DME subside with CFT less than 350 μm without accompanying fluid and cysts, repeated injection is mandatory in maximal 4-month interval.
dexamethasone implant
intravitreal dexamethasone implant injections in vitrectomized patients with DME
intravitreal ranibizumab
As for intravitreal ranibizumab 0.5 mg (IVR), we use OCT-guided treat-and-extend protocol for DME treatment after modifying the settings of TREX-DME study.4 The regimen include 3 monthly loading doses then extending the treatment injection interval one month more if CFT less than 350 μm without obvious submacular fluid and intramacular cysts. The injection interval shorten one month if CFT more than 350 μm or presence of obvious fluid and/or cysts. The patients are intentionally injected at most every 3 months even DME not existing.
Ranibizumab
intravitreal ranibizumab injections in vitrectomized patients with DME
Interventions
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dexamethasone implant
intravitreal dexamethasone implant injections in vitrectomized patients with DME
Ranibizumab
intravitreal ranibizumab injections in vitrectomized patients with DME
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Far Eastern Memorial Hospital
OTHER
Responsible Party
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Jia-Kang Wang
Chief of the Vitreoretinal Section of Ophthalmology Department
Principal Investigators
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Shu-Wen Chang, Ph. D.
Role: STUDY_CHAIR
Far Eastern Memorial Hospital
Locations
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Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Countries
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References
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Wang JK, Huang TL, Su PY, Chang PY. An updated review of long-term outcomes from randomized controlled trials in approved pharmaceuticals for diabetic macular edema. Eye Sci. 2015 Dec;30(4):176-83.
Sonoda S, Sakamoto T, Shirasawa M, Yamashita T, Otsuka H, Terasaki H. Correlation between reflectivity of subretinal fluid in OCT images and concentration of intravitreal VEGF in eyes with diabetic macular edema. Invest Ophthalmol Vis Sci. 2013 Aug 9;54(8):5367-74. doi: 10.1167/iovs.13-12382.
Muether PS, Droege KM, Fauser S. Vascular endothelial growth factor suppression times in patients with diabetic macular oedema treated with ranibizumab. Br J Ophthalmol. 2014 Feb;98(2):179-81. doi: 10.1136/bjophthalmol-2013-303954. Epub 2013 Nov 13.
Other Identifiers
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105136-E
Identifier Type: -
Identifier Source: org_study_id
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