Neovascular Age-related Macular Degeneration Clinical Trial
Official title:
A Multi-center, Open-Label, Phase 1, Single- and Multiple Ascending Dose Study to Assess Safety and Tolerability of PMC-403 in Subjects With Neovascular Age-related Macular Degeneration (nAMD).
This is a Phase 1 study, first-in-human (FIH), open label study to evaluate the safety, tolerability and identify the maximum tolerated dose (MTD) of PMC-403 and determine the recommended phase 2 dose (RP2D).
In this study, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) will be carried out in a sequential manner. - PART 1- SAD The SAD part of the study will be conducted in a step-wise manner for a total of 4 dose levels (0.7 mg, 2 mg, 3 mg, 4 mg). To each dose group, 3 subjects at minimum or 6 subjects at maximum will be recruited. In the SAD part, dose escalation will be performed up to 4 mg/eye (50 uL/eye) until the MTD is identified. In the SAD part, a maximum of 24 participants are to be enrolled. - PART 2- MAD Upon the end of the SAD part of the study, the MAD part is planned to be conducted in a step-wise manner for a total of 2 dose levels (3 mg, 4 mg). In the MAD part will begin with dose level 1 (3 mg). Subjects will be given a total of 3 doses of IP at 4-week intervals over a total period of 12 weeks and will be assessed for safety and tolerability according to study procedures. While a total of 6 subjects are to be recruited per dose group in the MAD part. Dose escalation will be performed up to 4 mg/eye (50 uL/eye) until the MTD is identified. In the MAD part, a maximum of 12 participants are to be enrolled. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04101877 -
The Sahlgrenska Anti-VEGF Study
|
Phase 2 | |
| Completed |
NCT03953079 -
A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD
|
Phase 2 | |
| Terminated |
NCT03577899 -
Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-1)
|
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 | |
| Completed |
NCT01926977 -
Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration
|
Phase 1/Phase 2 | |
| Recruiting |
NCT00370539 -
Combined PDT and Intravitreal Bevacizumab vs Combination of PDT, Intravitreal Bevacizumab and Triamcinolone for Neovascular AMD
|
Phase 3 | |
| Recruiting |
NCT03683251 -
Extension Study for the Port Delivery System With Ranibizumab (Portal)
|
Phase 3 | |
| Completed |
NCT03909425 -
Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography
|
||
| Completed |
NCT03744767 -
Adjuvant Anti-Mineralocorticoid-Receptor Treatment in Anti-VEGF Refractory Neovascular Age-Related Macular Degeneration
|
Phase 2 | |
| Recruiting |
NCT04690556 -
Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD
|
Phase 3 | |
| Completed |
NCT05281042 -
Home OCT Repeatability and Reproducibility of Automatic Fluid Quantification Study
|
||
| Completed |
NCT03677934 -
A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration
|
Phase 3 | |
| Recruiting |
NCT03594461 -
Intense Treatment Regimen With Intravitreal Aflibercept Injection
|
Phase 1/Phase 2 | |
| Completed |
NCT05131646 -
Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
|
||
| Completed |
NCT04537884 -
Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration
|
Phase 1 | |
| Completed |
NCT03216538 -
Safety and Efficacy of AS101 1% Oral Solution in Patients With Neovascular Age-Related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
| Completed |
NCT04304755 -
Zoledronic Acid as Adjuvant Therapy in Neovascular Age-related Macular Degeneration (Z-AMD)
|
Phase 2 | |
| Completed |
NCT01958918 -
Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD
|
Phase 4 | |
| Active, not recruiting |
NCT01918878 -
Aflibercept (EYLEA)as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration.
|
Phase 4 | |
| Completed |
NCT01712035 -
Neovascular Age-related Macular Degeneration
|