Diabetic Macular Edema Clinical Trial
Official title:
Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial
Diabetic macular edema (DME) is the main cause of severe vision loss in diabetic retinopathy. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) and Ozurdex are two safe and effective ways to treat DME. Pars plana vitrectomy is mainly suitable for the treatment of unabsorbed vitreous hemorrhage (VH) and tractional retinal detachment caused by proliferative diabetic retinopathy (PDR). Intraoperative optical coherence tomography (OCT), a diagnostic device, can be used to evaluate the potential condition of the retina. Many patients with PDR have unclear refractive stroma due to VH and other reasons, so preoperative OCT cannot give a clear diagnosis, so the use of intraoperative OCT can judge whether the patients are complicated with DME and give corresponding treatment. The purpose of this study is to explore the prognosis of patients with DME diagnosed by OCT during PPV and treated with PPV combined with aflibercept or PPV combined with Ozurdex, and to observe and compare the postoperative anatomical results, functional results, times of reinjections and the occurrence of adverse events between the two groups, in order to provide accurate treatment for patients, reduce the frequency of postoperative vitreous injection and lighten the burden of patients.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03953807 -
A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated
|
Phase 4 | |
| Completed |
NCT03622580 -
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
|
Phase 3 | |
| Recruiting |
NCT06262737 -
Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
|
||
| Terminated |
NCT04611152 -
A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
|
Phase 3 | |
| Terminated |
NCT04603937 -
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
|
Phase 3 | |
| Active, not recruiting |
NCT04108156 -
This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab
|
Phase 3 | |
| Completed |
NCT02867735 -
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
|
Phase 1 | |
| Withdrawn |
NCT03629210 -
Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema
|
Phase 2 | |
| Withdrawn |
NCT02842541 -
Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema
|
Phase 1 | |
| Completed |
NCT02221453 -
Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide
|
Phase 2 | |
| Completed |
NCT02979665 -
Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
|
||
| Completed |
NCT02556723 -
Intravitreal Injections of Ziv-aflibercept for Macular Diseases
|
N/A | |
| Completed |
NCT02000102 -
Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab
|
N/A | |
| Completed |
NCT02088229 -
Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema
|
N/A | |
| Terminated |
NCT00779142 -
Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies
|
N/A | |
| Completed |
NCT01171976 -
Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
|
Phase 3 | |
| Completed |
NCT00989989 -
Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema
|
Phase 3 | |
| Terminated |
NCT00768040 -
Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema
|
Phase 2 | |
| Completed |
NCT00683176 -
Effect of Choline Fenofibrate (SLV348) on Macular Edema
|
Phase 2 | |
| Completed |
NCT01259609 -
Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy
|
N/A |