Diabetic Macular Edema Clinical Trial
Official title:
OCT-angiography in Diabetic Patients: Qualitative Changes of the Intermediate and Deep Capillary Plexuses After Resolution of Macular Edema by Intravitreal Pharmacotherapy
Around the world there is an increasing incidence of diabetes mellitus, with millions of people affected. In this population, diabetic macular edema (DME) is the most common cause of visual impairment. While the visual impairment caused by EMD is variable, its early treatment can improve visual acuity and quality of life. The objective of this project is to use the new OCT-angiography technology, which evaluates macular capillary network without the need of intravenous injection of contrast, to assess macular microcirculatory network in its response to intravitreal pharmacological treatment of EMD. The resulting qualitative evaluation can be helpful in understanding the pathophysiology of visual loss associated with DME and in determining prognosis.
Patients who participate in this study will be selected among adults treated at the Retina Clinic and Ocular Oftalmologia clinics and will be aware of all stages of the research, formalizing the approval of their participation by informed consent term. The tests will be performed after pupillary dilation with 2 eye drops of tropicamide 1% (Mydriacyl, Alcon Laboratories), in Cirrus 5000 HD-OCT devices (Carl Zeiss Meditec - Dublin USA). Image acquisition protocols Optic Disc Cube 200x200 and 512x128 Macular Cube will be used, with analysis by RNFL protocols and NGO Analysis Report and Macular Cube Analysis Report, respectively. Subjective analysis of the examinations will be performed by the three authors of this project independently and then compared between them. ;
| 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 |
NCT01259609 -
Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy
|
N/A | |
| Completed |
NCT00683176 -
Effect of Choline Fenofibrate (SLV348) on Macular Edema
|
Phase 2 |