Phase 3
N=734
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT04005352 ↗Enrolled (actual)
734
Serious AEs
15.1%
Results posted
Jan 2024
Primary outcome: Primary: Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye — 141; 73; 131; 147 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brolucizumab 6 mg (Biological); Aflibercept 2 mg (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye |
141; 73; 131; 147; 94; 148 | <0.0001 sig |
| PRIMARY Average Change From Baseline at Week 28 and Week 32 in Best-corrected Visual Acuity (BCVA) - Study Eye |
5.2; 5.1 | <0.0001 sig |
| SECONDARY Distribution of the Last Interval With no Disease Activity up to Week 64 - Study Eye |
104; 45; 82; 88; 95; 81 | <0.0001 sig |
| SECONDARY Distribution of the Maximal Intervals With no Disease Activity up to Week 64 - Study Eye |
117; 57; 96; 92; 94; 114 | <0.0001 sig |
| SECONDARY Number of Participants With no Disease Activity - Study Eye |
87; 88; 260; 211 | 0.0510 |
| SECONDARY Time From Last Loading Injection to First Visit With No Disease Activity (Weeks) - 75th Percentile - Study Eye |
9.1; 12.1 | — |
| SECONDARY Time-to-first Dry Retina - Time to the First Visit With no Intraretinal Fluid (IRF) or Subretinal Fluid (SRF) - Study Eye |
330; 337; 144; 138; 70; 86 | — |
| SECONDARY Average Change From Baseline at Week 60 and Week 64 in Best-corrected Visual Acuity (BCVA) - Study Eye |
4.7; 4.9 | 0.8137 |
| SECONDARY Number of Participants With Best-corrected Visual Acuity Improvements of ≥ 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters up to Week 32/64 Per Treatment Arm - Study Eye |
88; 92; 89; 91 | 0.4106 |
| SECONDARY Number of Participants With Best-corrected Visual Acuity ≥ 69 Letters - Study Eye |
244; 228; 240; 219 | 0.2397 |
| SECONDARY Average Change From Baseline in Central Subfield Thickness (CSFT) - Study Eye |
-166.9; -140.0; -182.9; -167.5 | 0.0066 sig |
| SECONDARY Number of Participants With Presence of Intraretinal Fluid and/or Subretinal Fluid in the Central Subfield - Study Eye |
175; 198; 144; 152; 60; 69 | — |
| SECONDARY Number of Participants With Presence of Sub-Retinal Pigment Epithelium Fluid in the Central Subfield - Study Eye |
173; 208; 156; 175; 27; 31 | — |
| SECONDARY Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Composite Scores - Study Eye |
4.09; 3.72; 2.8; 4.7 | 0.193 |
| SECONDARY Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - General Vision - Study Eye |
7.94; 5.79; 7.3; 8.0 | 0.081 |
| SECONDARY Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Ocular Pain - Study Eye |
3.55; 2.78; 3.1; 5.0 | 0.558 |
| SECONDARY Change From Baseline n Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Near Activities - Study Eye |
7.46; 5.86; 4.9; 7.9 | 0.287 |
| SECONDARY Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Distance Activities - Study Eye |
3.06; 3.78; 2.5; 5.0 | 0.602 |
| SECONDARY Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Social Functioning - Study Eye |
1.99; 0.43; 0.2; 1.7 | 0.174 |
| SECONDARY Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Mental Health - Study Eye |
5.83; 6.79; 5.0; 7.2 | 0.499 |
| SECONDARY Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Role Difficulties - Study Eye |
5.17; 4.30; 4.7; 5.9 | 0.643 |
| SECONDARY Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Dependency - Study Eye |
2.71; 2.22; -0.6; 2.2 | 0.700 |
| SECONDARY Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Driving - Study Eye |
4.92; 4.19; 1.3; 3.0 | 0.741 |
| SECONDARY Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Color Vision - Study Eye |
1.78; 0.02; 0.1; 1.2 | 0.054 |
| SECONDARY Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Peripheral Vision - Study Eye |
3.24; 2.00; 2.5; 3.0 | 0.394 |
| SECONDARY Number of Participants With Treatment Emergent Ocular Adverse Events (Greater Than or Equal to 1% in Any Treatment Arm) by Preferred Term for the Study Eye |
114; 102; 23; 13; 16; 18 | — |
| SECONDARY Number of Participants With Treatment Emergent Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) - Summary Table |
182; 185 | — |
Summary
This was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth factor (VEGF) treatment.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent must be obtained prior to participation in the study
- Male or female patients ≥ 50 years of age at screening who are treatment naive
- Active choroidal neovascularization (CNV) secondary to AMD that affects the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography and sequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema (study eye)
- Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the central subfield, as seen by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye)
- Best-corrected visual acuity (BCVA) score between 83 and 38 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye)
Exclusion Criteria
- Ocular conditions/disorders at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye)
- Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)
- Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline (study eye)
- Ocular treatments: previous treatment with any anti-vascular endothelial growth factor (VEGF) drugs or investigational drugs, intraocular or periocular steroids, macular laser photocoagulation, photodynamic therapy, vitreoretinal surgery, intraocular surgery (study eye)
- Stroke or myocardial infarction during the 6-month period prior to baseline
- Systemic anti-VEGF therapy at any time.
Data sourced from ClinicalTrials.gov (NCT04005352). 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.