Ranibizumab vs Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema
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|ClinicalTrials.gov Identifier: NCT04089605|
Recruitment Status : Completed
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Drug: dexamethasone implant Drug: Ranibizumab||Phase 4|
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 patients. Intravitreal injections of anti-VEGF agents or corticosteroid are required for treating diabetic macular edema (DME) in vitrectomized eyes. Intraocular levels of various cytokines may alter in the diabetic eyes following vitrectomy. Pharmacokinetics may be different between various intraocular agents in vitrectomized eyes. Herein our study will prospectively randomize to compare the clinical behavior between intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) in vitrectomized patients with DME. To our knowledge, it is the first study involving such subject.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ranibizumab and Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||November 1, 2018|
|Actual Study Completion Date :||April 30, 2019|
Experimental: 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.
Drug: dexamethasone implant
intravitreal dexamethasone implant injections in vitrectomized patients with DME
Other Name: Dexamethasone implants (Ozurdex®, Allergan Inc., Irvine, CA, USA)
Active Comparator: 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.
intravitreal ranibizumab injections in vitrectomized patients with DME
Other Name: (Lucentis®, Ranibizumab (Novartis Pharma AG, Basel, Switzerland, and Genentech Inc., South San Francisco, CA, USA)
- BCVA at Month 6 [ Time Frame: Month 6 ]best-corrected visual acuity (BCVA) at the end of intervention
- CFT at Month 6 [ Time Frame: Month 6 ]central foveal thickness (CFT) at the end of intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089605
|Far Eastern Memorial Hospital|
|New Taipei, Taiwan, 105|
|Study Chair:||Shu-Wen Chang, Ph. D.||Far Eastern Memorial Hospital|