Diabetic Macular Edema (DME) Clinical Trial
Official title:
A 2-part Study Consisting of an Open-label Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Single-masked Comparative Safety and Preliminary Efficacy Study of Intravitreal (IVT) EYE103 in a Mixed Population of Participants With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01702441 -
Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04543331 -
Observational Study to Evaluate Fluid Resolution and Effectiveness in Patients Receiving Beovu in Neovascular Age-related Macular Degeneration and Visual Impairment Due to Diabetic Macular Edema
|
||
Completed |
NCT02424019 -
Phase 4 IOP Signals Associated With ILUVIEN®
|
Phase 4 | |
Completed |
NCT02633852 -
Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen of Aflibercept (EYLEA) as a Second Line Treatment for Diabetic Macular Edema
|
Phase 4 | |
Completed |
NCT04857996 -
Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD)
|
Phase 2 | |
Completed |
NCT04739306 -
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
|
Phase 3 | |
Recruiting |
NCT06116916 -
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
|
Phase 2 | |
Completed |
NCT02050828 -
The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema
|
Phase 2 | |
Recruiting |
NCT03859245 -
Photobiomodulation & Ketogenic Diet for Treatment of Mid-periphery Retinal Disorders for Alzheimer's Disease Prevention
|
N/A | |
Completed |
NCT02585401 -
Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada
|
N/A | |
Terminated |
NCT02080091 -
Observational Study to Assess the Effect of Iluvien® in DME Patients Insufficiently Responsive to Available Therapies
|
N/A | |
Terminated |
NCT04697758 -
Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema
|
Phase 1/Phase 2 | |
Terminated |
NCT00936520 -
SAR 1118 in Human Subjects Undergoing Pars Plana Vitrectomy
|
Phase 1 | |
Not yet recruiting |
NCT06398080 -
An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting
|
||
Active, not recruiting |
NCT05989126 -
Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
|
Phase 3 |