Clinical Trials Logo

Clinical Trial Summary

The study is a prospective and retrospective, observational, single-arm, non-randomized cohort study of ocular treatment with intravitreal injections of brolucizumab in nAMD patients. This study will be conducted prospectively and retrospectively (for patients who had their first brolucizumab injection before study start) using data collected in a standardized manner.


Clinical Trial Description

Retrospective data will be collected for all patients starting treatment with brolucizumab for up to 12 months before baseline. Patients who received brolucizumab before the study start will be recruited into the study and presented an informed consent form (ICF) at their first visit. Their index date will be the date of their first brolucizumab injection, which must have occurred during the recruitment period or in 6 months prior to the first visit in the recruitment period. Patient history and characteristics will be recorded in the 12 months prior to the index date. Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in the patient study eye. Index period: The patients fulfilling the inclusion criteria will be identified during the period 01-Nov-2021 and onwards. Study period: The period is between May-2020 and Nov-2023 to allow 6-month pre-index period and at least a 12-month follow-up period for each recruited patient. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05266495
Study type Observational
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email novartis.email@novartis.com
Status Recruiting
Phase
Start date April 13, 2022
Completion date September 30, 2024

See also
  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