Phase 3
N=248
An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study
Neovascular Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT04597632 ↗Enrolled (actual)
248
Serious AEs
10.5%
Results posted
Apr 2024
Primary outcome: Primary: Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye — 68; 59; 47; 49 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- brolucizumab (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye |
68; 59; 47; 49; 14 | — |
| PRIMARY Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye |
-1.8; -2.9; -2.3 | — |
| SECONDARY Average Change in Central Subfield Thickness (CSFT) From Baseline to Week 52 and Week 56 - Study Eye |
5.9; -14.1; -3.3 | — |
| SECONDARY Number (%) of Subjects With Presence of IRF and/or SRF, and Sub-RPE Fluid in the Study Eye at Week 52 and Week 56 Overall and by Core Study Treatment Arm |
10; 14; 24; 93; 76; 169 | — |
| SECONDARY Last Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study by Core Study Randomized Treatment Arm |
49; 19; 29; 30; 21; 26 | — |
| SECONDARY Maximal Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study |
54; 20; 28; 31; 23; 34 | — |
| SECONDARY Number (%) of Subjects With Change in Duration of Last Interval With no Disease Activity Between Baseline of the Extension Study and Week 56 by Core Study Treatment Arm |
0; 2; 8; 5; 21; 32 | — |
| SECONDARY Treatment-emergent Ocular Adverse Events (Greater Than or Equal to 1.0%) by Preferred Term for the Study Eye |
63; 9; 6; 6; 5; 4 | — |
| SECONDARY Treatment-emergent Non-ocular Adverse Events (Greater Than or Equal to 2%) by Preferred Term |
82; 10; 8; 7; 5 | — |
Summary
The purpose of this extension study was to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective was to assess brolucizumab's potential for long durability up to 20 weeks.
All eligible participants were treated with brolucizumab regardless of their treatment in the TALON study.
The study period was 56 weeks including post-treatment follow-up.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Successfully completed TALON core study at week 64 (End of Study)
Exclusion Criteria
- Medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator
- Discontinued study treatment in the core study
- Anti-VEGF treatment is futile in the study eye, in the Investigator's opinion.
- Pregnant or nursing (lactating) women
- Women of child-bearing potential not using highly effective methods of contraception
Data sourced from ClinicalTrials.gov (NCT04597632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.