Diabetic Macular Edema Clinical Trial
Official title:
Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
Diabetic macular oedema (DME) is the main cause of visual impairment (or visual acuity) in patients with diabetic retinopathy, as it leads to progressive thickening of the retina, which in the long term leads to progressive death of the photoreceptor cells. It is therefore important to continue to treat macular oedema that has been progressing for several months or even years (resistant DME). The management of DME necessarily involves controlling diabetes (improving glycated haemoglobin levels) and blood pressure, but this is often not enough. Thus, when DME is significant and leads to a decrease in visual acuity, treatments are administered directly into the eye (intravitreal injections). For some years now, corticosteroids have been injected into the vitreous body (the gel that fills the eyeball) through the white of the eye for their anti-inflammatory properties. Indeed, these drugs improve the permeability of the retinal vessels and thus reduce oedema. These intravitreal implants are most often used in patients who have already undergone cataract surgery (pseudophakic) because corticosteroids also tend to aggravate a cataract. Currently, there are two implants containing corticosteroids that can be injected: the dexamethasone implant and the fluocinolone acetonide implant. These two implants have different properties, particularly with regard to their duration of action. Today, the overall management at 3 years and the quality of life associated with the treatments deserve to be evaluated. This study is the first multicenter controlled trial comparing the two reference corticosteroid treatments in terms of overall cost of treatment and follow-up and patient quality of life, while considering their efficacy and side effects. This evaluation will make it possible to precisely define the respective place of each implant in the management of resistant DME.
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 |
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 | |
| 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 | |
| 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 | |
| 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 | |
| Terminated |
NCT00768040 -
Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema
|
Phase 2 |