Diabetic Macular Edema Clinical Trial
Official title:
Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser
The goal of this pilot study is to investigate the safety and efficacy of micropulse (MP) macular laser in combination with intravitreal aflibercept for the treatment of centre-involved diabetic macular edema.
Diabetic macular edema (DME) is one of the major causes of visual decline among diabetic
patients. Early Treatment of Diabetic Retinopathy Study has established focal/grid macular
laser as the standard of treatment for clinically significant macular edema. More recently,
intravitreal injections of anti-VEGF agents, either as monotherapy or in combination with
focal/grid laser, have proven to be superior for the treatment of DME compared to laser
alone.
Micropulse (MP) macular laser involves applying the laser in a fraction of the time within
very small pockets of energy. Unline traditional focal/grid macular laser, the micropulse
method of delivery does not leave any visible burns on the retina.
A recent release by the Diabetic Retinopathy Clinical Research Network has shown that
deferring focal/grid laser and treating diabetic macular edema with only anti-VEGF may lead
to better visual outcomes. Since MP laser does not have the undesired side effect of leaving
laser scars on the macula, the study is to show that prompt MP laser in addition to anti-vegf
injections may lead to better visual outcomes and/or decreased treatment burden without the
undesired side effect of macular scarring.
;
| 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 |