Neovascular Age-related Macular DegenerationPhase 3TALON ExtNCT04597632
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
A Phase 3 study testing brolucizumab in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 60 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- brolucizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 60 sitesin 16 countries
- Study dates
- 16 Dec 2020to 28 Mar 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Successfully completed TALON core study at week 64 (End of Study)
Who cannot join
- 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
Trial locations and contacts
60 sites in 16 countries.
60 sites in 16 countries
France10 sites
Novartis Investigative Site
Bordeaux, 33000
Novartis Investigative Site
Créteil, 94000
Novartis Investigative Site
Lyon, Rhone, 69317
Novartis Investigative Site
Marseille, F 13008
Novartis Investigative Site
Montauban, 82000
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Rueil-Malmaison, 92500
Novartis Investigative Site
Saint-Cyr-sur-Loire, Indre Et Loire, 37540
Spain8 sites
Novartis Investigative Site
Barcelona, Catalonia, 08022
Novartis Investigative Site
Barcelona, 08024
Novartis Investigative Site
Barcelona, 08025
Novartis Investigative Site
Burjassot, Valencia, 46100
Novartis Investigative Site
Córdoba, 14012
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, 08190
Novartis Investigative Site
Zaragoza, 50009
Australia7 sites
Novartis Investigative Site
Albury, New South Wales, 2640
Novartis Investigative Site
Glen Waverley, Victoria, 3150
Novartis Investigative Site
Hurstville, New South Wales, 2220
Novartis Investigative Site
Nedlands, Western Australia, 6009
Novartis Investigative Site
Parramatta, New South Wales, 2150
Novartis Investigative Site
Rowville, Victoria, 3179
Novartis Investigative Site
Sydney, New South Wales, 2000
South Korea6 sites
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
Novartis Investigative Site
Busan, 49241
Novartis Investigative Site
Daegu, 705703
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Novartis Investigative Site
Seoul, 05505
Novartis Investigative Site
Seoul, 07301
United States5 sites
Novartis Investigative Site
Fort Lauderdale, Florida, 33309
Novartis Investigative Site
Germantown, Tennessee, 38138
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Indianapolis, Indiana, 46280
Novartis Investigative Site
Minneapolis, Minnesota, 55435
Czechia3 sites
Novartis Investigative Site
Hradec Králové, CZE, 500 05
Novartis Investigative Site
Prague, 100 34
Novartis Investigative Site
Prague, 12808
Germany3 sites
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Mainz, 55131
Israel3 sites
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Ramat Gan, 52621
Novartis Investigative Site
Tsrifin, 6093000
Malaysia3 sites
Novartis Investigative Site
Batu Caves, Selangor, 68100
Novartis Investigative Site
Malacca, Melaka Malaysia, 75000
Novartis Investigative Site
Shah Alam, Selangor, 40000
Taiwan3 sites
Novartis Investigative Site
Taipei, 103616
Novartis Investigative Site
Taipei, 11217
Novartis Investigative Site
Taoyuan, 33305
Netherlands2 sites
Novartis Investigative Site
's-Hertogenbosch, 5223 GZ
Novartis Investigative Site
Nijmegen, 6525 EX
Portugal2 sites
Novartis Investigative Site
Porto, 4099-001
Novartis Investigative Site
Vila Franca de Xira, 2600-009
Sweden2 sites
Novartis Investigative Site
Örebro, 701 85
Novartis Investigative Site
Västerås, 72189
About this study
Official title: A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study
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.
Read the detailed description
This was a 56-week, open-label, one-arm extension study in subjects who had completed the CRTH258A2303 (TALON) (NCT04005352) study, referred to as the core study in this document. Subjects who provided written informed consent and met all the inclusion and none of the exclusion criteria were enrolled into this extension study to receive brolucizumab 6 mg in a treat-to-control (TtC) regimen, irrespective of the treatment received in the core study.
The maximum study duration for a subject was 56 weeks, including post-treatment follow-up.
There were two periods in this study:
- Treat-to-Control treatment period: from Baseline (Day 1) to Week 52
- Post-treatment follow-up period: from Week 52 to Week 56.
All participants were treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept).
Treatment intervals were then extended by 4 weeks at a time based on the investigator's judgment of visual and/or anatomic outcomes. The treatment intervals were to have been 4 weeks at a time if disease activity recurs.
- Being tested
- brolucizumab
- Keywords
- neovascular age-related macular degeneration, wet age-related macular degeneration, wet AMD, choroidal neovascularization, individualized treatment, anti-VEGF, Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration
- Medical subject headings
- Choroidal Neovascularization, Macular Degeneration, Vision Disorders, Geographic Atrophy, Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brolucizumabDrug
Also called RTH258
brolucizumab 6 mg/0.05 mL solution for intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| brolucizumab 6 mg | Experimental | Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity. Receives: Drug: brolucizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye
Number of subjects in every 4 weeks (q4w), every 8 weeks (q8w), every 12 weeks (q12w) and every 20 weeks (q20w) intervals at last interval with no disease activity up to Week 56. 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
Measured: Up to Week 56
Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye
Best-Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
The average change in BCVA from Baseline of the extension study at Week 52 and Week 56 was estimated by an analysis of variance (ANOVA) with baseline age categories, baseline BCVA categories and treatment arm in the core study included as fixed effects. Last observation carried forward (LOCF) was used to impute missing BCVA values.
Measured: Extension study baseline, average of Week 52 and Week 56
Secondary outcomes (7)
Average Change in Central Subfield Thickness (CSFT) From Baseline to Week 52 and Week 56 - Study Eye
Central Subfield Thickness (μm): Analysis of Variance (ANOVA) results for the average change from extension study Baseline at Week 52 and Week 56 for the study eye in the extension study by core study treatment arm.
Central Subfield Thickness was assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
Measured: Extension study baseline, average of Week 52 and Week 56
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
Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) status in the central subfield as assessed by Spectral Domain Ocular Coherence Tomography (SD-OCT): Number (%) of subjects with presence of IRF and/or SRF, and sub-Retinal Pigment Epithelium (RPE) fluid in the study eye at Week 52 and Week 56 overall and by core study treatment arm
Measured: Weeks 52 and 56
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
Duration of the last interval with no disease activity up to Week 52 by core study treatment arm.
Measured: up to Week 56
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
Duration of the maximal intervals with no disease activity up to Week 52 by core study treatment arm.
Measured: up to Week 56
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
Change in last interval with no disease activity
Measured: Extension study baseline, up to Week 56
Treatment-emergent Ocular Adverse Events (Greater Than or Equal to 1.0%) by Preferred Term for the Study Eye
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Measured: Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.
Treatment-emergent Non-ocular Adverse Events (Greater Than or Equal to 2%) by Preferred Term
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Measured: Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start16 Dec 2020
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597632
- Sponsor's protocol ID
- CRTH258A2303E1
- Other IDs
- 2020-002349-40
- Acronym
- TALON Ext
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2020
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study
- ClinicalTrials.gov ID
- NCT04597632
- Acronym / sponsor ID
- TALON Ext / CRTH258A2303E1
- Keywords
- neovascular age-related macular degeneration, wet age-related macular degeneration, wet AMD, choroidal neovascularization, individualized treatment, anti-VEGF, Macular degeneration, age-related macular degeneration (ARMD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 4 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a 56-week, open-label, one-arm extension study in subjects who had completed the CRTH258A2303 (TALON) (NCT04005352) study, referred to as the core study in this document. Subjects who provided written informed consent and met all the inclusion and none of the exclusion criteria were enrolled into this extension study to receive brolucizumab 6 mg in a treat-to-control (TtC) regimen, irrespective of the treatment received in the core study.
The maximum study duration for a subject was 56 weeks, including post-treatment follow-up.
There were two periods in this study:
- Treat-to-Control treatment period: from Baseline (Day 1) to Week 52
- Post-treatment follow-up period: from Week 52 to Week 56.
All participants were treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept).
Treatment intervals were then extended by 4 weeks at a time based on the investigator's judgment of visual and/or anatomic outcomes. The treatment intervals were to have been 4 weeks at a time if disease activity recurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brolucizumab 6 mg | Experimental | Drug: brolucizumabParticipants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent
- Successfully completed TALON core study at week 64 (End of Study)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brolucizumabAlso: RTH258brolucizumab 6 mg/0.05 mL solution for intravitreal injection | Drug | brolucizumab 6 mg |
Primary outcome
Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye
Time frame: Up to Week 56
Number of subjects in every 4 weeks (q4w), every 8 weeks (q8w), every 12 weeks (q12w) and every 20 weeks (q20w) intervals at last interval with no disease activity up to Week 56. 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
Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye
Time frame: Extension study baseline, average of Week 52 and Week 56
Best-Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. The average change in BCVA from Baseline of the extension study at Week 52 and Week 56 was estimated by an analysis of variance (ANOVA) with baseline age categories, baseline BCVA categories and treatment arm in the core study included as fixed effects. Last observation carried forward (LOCF) was used to impute missing BCVA values.
7 secondary outcomes
Average Change in Central Subfield Thickness (CSFT) From Baseline to Week 52 and Week 56 - Study Eye
Time frame: Extension study baseline, average of Week 52 and Week 56
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
Time frame: Weeks 52 and 56
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
Time frame: up to Week 56
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
Time frame: up to Week 56
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
Time frame: Extension study baseline, up to Week 56
Treatment-emergent Ocular Adverse Events (Greater Than or Equal to 1.0%) by Preferred Term for the Study Eye
Time frame: Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.
Treatment-emergent Non-ocular Adverse Events (Greater Than or Equal to 2%) by Preferred Term
Time frame: Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
60 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing brolucizumab in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 60 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in France, Spain, Australia, South Korea, United States and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye (time frame: Up to Week 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.