Diabetic Macular Edema (DME) Clinical Trial
Official title:
Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME)
This study is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with Diabetic Macular Edema (DME).
Upon providing informed consent, subjects will be sequentially enrolled into the study. Decision regarding dose escalation will be based on the recommendation from the Data Monitoring Committee (DMC). The first 3 eligible subjects will receive the low dose of AXT107 injection. After the 3 low dose subjects complete a 7-day follow-up, the DMC will review their safety data. If an acceptable safety profile is determined by the DMC, 3 additional subjects will be enrolled to receive the mid dose of AXT107 injection. Upon completion of a 7-day follow-up, review of the safety data, and determination of an acceptable safety profile by the DMC for the mid dose subjects, 3 additional subjects will be enrolled to receive the high dose of AXT107 injection. ;
| 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 | |
| Recruiting |
NCT05919693 -
A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
|
Phase 1/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 |
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 |