Neovascular Age-Related Macular Degeneration Clinical Trial
Official title:
A Two-year, Randomized, Double-masked, Multicenter, Two-arm Study Comparing the Efficacy and Safety of RTH258 6 mg Versus Aflibercept in Subjects With Neovascular Age-related Macular Degeneration
The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection (6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.
Subjects were randomized to brolucizumab 6 mg and aflibercept 2 mg in a 1:1 ratio. Subjects
in both treatment arms received 3 monthly loading doses (Day 0, Week 4 and Week 8), followed
by a maintenance regimen, until the end of the study (Week 96/Exit). All subjects attended
pre-specified visits every 4 weeks.
Subjects in the brolucizumab 6 mg arm followed a q12w/q8w maintenance regimen. Within the
q12w/q8w regimen, the initial treatment after the loading phase was q12w (1 injection every
12 weeks). If disease activity was identified by the masked investigator at any of the
disease activity assessments, dosing was adjusted to q8w (1 injection every 8 weeks)
("q12w/q8w regimen"). Once subjects were adjusted to the q8w interval, they stayed on that
interval until the end of the study.
Subjects in the aflibercept 2 mg arm followed a q8w maintenance regimen until the end of the
study.
Results reported up to Week 48 are based on the database locked for the primary analysis at
Week 48. Results reported after Week 48 are based on the database locked at the end of study
(final analysis).
;
| 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
|