Novartis Investigative Site |
Phoenix, Arizona, United States, 85020 |
Novartis Investigative Site |
Phoenix, Arizona, United States, 85021 |
Novartis Investigative Site |
Huntington Beach, California, United States, 92647 |
Novartis Investigative Site |
Loma Linda, California, United States, 92354 |
Novartis Investigative Site |
Los Angeles, California, United States, 90033 |
Novartis Investigative Site |
Riverside, California, United States, 92505 |
Novartis Investigative Site |
Sacramento, California, United States, 95817 |
Novartis Investigative Site |
Santa Ana, California, United States, 92705 |
Novartis Investigative Site |
Torrance, California, United States, 90505 |
Novartis Investigative Site |
Ventura, California, United States, 93003 |
Novartis Investigative Site |
Fort Lauderdale, Florida, United States, 33309 |
Novartis Investigative Site |
Fort Myers, Florida, United States, 33912-7125 |
Novartis Investigative Site |
Orlando, Florida, United States, 32789 |
Novartis Investigative Site |
Pinellas Park, Florida, United States, 33782 |
Novartis Investigative Site |
Winter Haven, Florida, United States, 33880 |
Novartis Investigative Site |
Atlanta, Georgia, United States, 30342 |
Novartis Investigative Site |
Bloomington, Illinois, United States, 61704 |
Novartis Investigative Site |
Chicago, Illinois, United States, 60657 |
Novartis Investigative Site |
Springfield, Illinois, United States, 62704 |
Novartis Investigative Site |
Indianapolis, Indiana, United States, 46280 |
Novartis Investigative Site |
West Des Moines, Iowa, United States, 50266 |
Novartis Investigative Site |
Shawnee Mission, Kansas, United States, 66204 |
Novartis Investigative Site |
Minneapolis, Minnesota, United States, 55435 |
Novartis Investigative Site |
Kansas City, Missouri, United States, 64133 |
Novartis Investigative Site |
Hickory, North Carolina, United States, 28602 |
Novartis Investigative Site |
Portland, Oregon, United States, 97210 |
Novartis Investigative Site |
Springfield, Oregon, United States, 97477 |
Novartis Investigative Site |
Germantown, Tennessee, United States, 38138 |
Novartis Investigative Site |
Abilene, Texas, United States, 79606 |
Novartis Investigative Site |
Austin, Texas, United States, 78705 |
Novartis Investigative Site |
Bellaire, Texas, United States, 77401 |
Novartis Investigative Site |
Fort Worth, Texas, United States, 76104 |
Novartis Investigative Site |
Harlingen, Texas, United States, 78550 |
Novartis Investigative Site |
Houston, Texas, United States, 77025 |
Novartis Investigative Site |
Houston, Texas, United States, 77025 |
Novartis Investigative Site |
Houston, Texas, United States, 77030 |
Novartis Investigative Site |
San Antonio, Texas, United States, 78240 |
Novartis Investigative Site |
San Antonio, Texas, United States, 78240 |
Novartis Investigative Site |
Lynchburg, Virginia, United States, 24502 |
Novartis Investigative Site |
Madison, Wisconsin, United States, 53705-3611 |
Novartis Investigative Site |
Caba, Buenos Aires, Argentina, 1116 |
Novartis Investigative Site |
Rosario, Provincia De Santa Fe, Argentina |
Novartis Investigative Site |
Caba, Argentina |
Novartis Investigative Site |
Ciudad Autonoma de Bs As, Argentina, C1015ABO |
Novartis Investigative Site |
Albury, New South Wales, Australia, 2640 |
Novartis Investigative Site |
Hurstville, New South Wales, Australia, 2220 |
Novartis Investigative Site |
Parramatta, New South Wales, Australia, 2150 |
Novartis Investigative Site |
Sydney, New South Wales, Australia, 2000 |
Novartis Investigative Site |
Southport, Queensland, Australia, 4215 |
Novartis Investigative Site |
Glen Waverley, Victoria, Australia, 3150 |
Novartis Investigative Site |
Rowville, Victoria, Australia, 3179 |
Novartis Investigative Site |
Nedlands, Western Australia, Australia, 6009 |
Novartis Investigative Site |
Linz, Upper Austria, Austria, 4021 |
Novartis Investigative Site |
Vienna, Austria, 1090 |
Novartis Investigative Site |
Wien, Austria, A-1140 |
Novartis Investigative Site |
Alken, Belgium, 3570 |
Novartis Investigative Site |
Brussel, Belgium, 1020 |
Novartis Investigative Site |
Leuven, Belgium, 3000 |
Novartis Investigative Site |
Brampton, Ontario, Canada, L6Y 0P6 |
Novartis Investigative Site |
London, Ontario, Canada, N6A 4G5 |
Novartis Investigative Site |
Ottawa, Ontario, Canada, K1H 8L6 |
Novartis Investigative Site |
Toronto, Ontario, Canada, M3C 0G9 |
Novartis Investigative Site |
Toronto, Ontario, Canada, M4N 3M5 |
Novartis Investigative Site |
Toronto, Ontario, Canada, M5T 2S8 |
Novartis Investigative Site |
Boisbriand, Quebec, Canada, J7H 1S6 |
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Quebec, Canada, G1S 4L8 |
Novartis Investigative Site |
Brno Bohunice, Czech Republic, Czechia, 625 00 |
Novartis Investigative Site |
Zlin, Czech Republic, Czechia, 762 75 |
Novartis Investigative Site |
Hradec Kralove, CZE, Czechia, 500 05 |
Novartis Investigative Site |
Ostrava Poruba, Czechia, 708 52 |
Novartis Investigative Site |
Praha 10, Czechia, 100 34 |
Novartis Investigative Site |
Praha, Czechia, 12808 |
Novartis Investigative Site |
Saint Cys Sur Loire, Indre Et Loire, France, 37540 |
Novartis Investigative Site |
Bordeaux, France, 33000 |
Novartis Investigative Site |
Creteil, France, 94000 |
Novartis Investigative Site |
Lyon Cedex 04, France, 69317 |
Novartis Investigative Site |
Marseille, France, F 13008 |
Novartis Investigative Site |
Montauban, France, 82000 |
Novartis Investigative Site |
Nantes Cedex 1, France, 44093 |
Novartis Investigative Site |
Paris cedex 10, France, 75010 |
Novartis Investigative Site |
Paris, France, 75015 |
Novartis Investigative Site |
Rueil Malmaison, France, 92500 |
Novartis Investigative Site |
Strasbourg, France, 67000 |
Novartis Investigative Site |
Berlin, Germany, 10713 |
Novartis Investigative Site |
Berlin, Germany, 13353 |
Novartis Investigative Site |
Bonn, Germany, 53105 |
Novartis Investigative Site |
Duesseldorf, Germany, 40212 |
Novartis Investigative Site |
Freiburg, Germany, 79106 |
Novartis Investigative Site |
Gottingen, Germany, 37075 |
Novartis Investigative Site |
Kempten, Germany, 87435 |
Novartis Investigative Site |
Leipzig, Germany, 04103 |
Novartis Investigative Site |
Mainz, Germany, 55131 |
Novartis Investigative Site |
Muenster, Germany, 48145 |
Novartis Investigative Site |
Muenster, Germany, 48149 |
Novartis Investigative Site |
Ulm, Germany, 89075 |
Novartis Investigative Site |
Jerusalem, Israel, 91120 |
Novartis Investigative Site |
Ramat Gan, Israel, 52621 |
Novartis Investigative Site |
Tel Aviv, Israel, 64239 |
Novartis Investigative Site |
Zerifin, Israel, 6093000 |
Novartis Investigative Site |
Bologna, BO, Italy, 40138 |
Novartis Investigative Site |
Genova, GE, Italy, 16132 |
Novartis Investigative Site |
Milano, MI, Italy, 20100 |
Novartis Investigative Site |
Milano, MI, Italy, 20122 |
Novartis Investigative Site |
Milano, MI, Italy, 20132 |
Novartis Investigative Site |
Palermo, PA, Italy, 90127 |
Novartis Investigative Site |
Perugia, PG, Italy, 06100 |
Novartis Investigative Site |
Novara, Italy, 28100 |
Novartis Investigative Site |
Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620 |
Novartis Investigative Site |
Seoul, Seocho Gu, Korea, Republic of, 06591 |
Novartis Investigative Site |
Busan, Korea, Republic of, 602739 |
Novartis Investigative Site |
Daegu, Korea, Republic of, 705703 |
Novartis Investigative Site |
Seoul, Korea, Republic of, 05505 |
Novartis Investigative Site |
Seoul, Korea, Republic of, 07301 |
Novartis Investigative Site |
Melaka, Melaka Malaysia, Malaysia, 75000 |
Novartis Investigative Site |
Batu Caves, Selangor, Malaysia, 68100 |
Novartis Investigative Site |
Shah Alam, Selangor, Malaysia, 40000 |
Novartis Investigative Site |
July 1, 2019
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July 2, 2019
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June 7, 2021
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September 25, 2019
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November 23, 2022 (Final data collection date for primary outcome measure)
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Same as current
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- Distribution of the last interval with no disease activity [ Time Frame: Up to Week 64 ]
Treatment interval distribution
- Distribution of the maximal intervals with no disease activity [ Time Frame: Up to Week 64 ]
Treatment interval distribution
- Proportion of patients with no disease activit [ Time Frame: At Weeks 14 and 16 ]
Disease activity assessment
- Time from the last loading injection to the first visit with no disease activity [ Time Frame: Week 8 to week 62 ]
Disease activity assessment
- Average change in Best-corrected visual acuity [ Time Frame: At Weeks 60 and 64 ]
Visual acuity test
- Occurrence of Best-corrected visual acuity improvements of ≥ 10 and ≥ 15 letters [ Time Frame: At Week 32, Week 64, and at the last injection visit ]
Visual acuity test
- Occurrence of Best-corrected visual acuity ≥ 69 letters [ Time Frame: At Week 32, at Week 64, and at the last injection visit ]
Visual acuity test
- Average change from baseline in Central Subfield Thickness [ Time Frame: At Weeks 28 and 32 ]
Spectral Domain Optical Coherence Tomography
- Average change from baseline in Central Subfield Thickness [ Time Frame: At Weeks 60 and 64 ]
Spectral Domain Optical Coherence Tomography
- Number of visits with presence of Intraretinal Fluid and/or Subretinal Fluid, and sub-Retinal Pigment Epithelium fluid in the central subfield [ Time Frame: At Weeks 28 and 32 ]
Spectral Domain Optical Coherence Tomography
- Number of visits with presence of Intraretinal Fluid and/or Subretinal Fluid, and sub-Retinal Pigment Epithelium fluid in the central subfield [ Time Frame: At Weeks 60 and 64 ]
Spectral Domain Optical Coherence Tomography
- Change in Visual Function Questionnnaire-25 [ Time Frame: At Weeks 32 and 64 ]
Visual Function Questionnnaire-25
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Same as current
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Not Provided
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Not Provided
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Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
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A 64-week, Two-arm, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen in Patients With Neovascular Agerelated Macular Degeneration (TALON)
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The study is a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with nAMD (neovascular age related macular degeneration) who have not previously received anti-VEGF (vascular endothelial growth factor) treatment. Patients who consent will undergo screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria.
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Not Provided
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Interventional
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Phase 3
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Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Double arm, multi-center Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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- Age-related Macular Degeneration
- Macular Degeneration
- Wet Macular Degeneration
- Retinal Degeneration
- Retinal Diseases
- Eye Diseases
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- Biological: Brolucizumab 6 mg
3 x 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62.
Other Name: RTH258
- Biological: Aflibercept 2 mg
3 x 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62
Other Name: EYLEA
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Not Provided
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Recruiting
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692
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330
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January 6, 2023
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November 23, 2022 (Final data collection date for primary outcome measure)
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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.
Other protocol-defined inclusion/exclusion criteria may apply
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Sexes Eligible for Study: |
All |
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50 Years and older (Adult, Older Adult)
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No
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Contact: Novartis Pharmaceuticals |
1-888-669-6682 |
novartis.email@novartis.com |
|
Contact: Novartis Pharmaceuticals |
+41613241111 |
|
|
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Argentina, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, Portugal, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
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|
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NCT04005352
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CRTH258A2303
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No
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Plan to Share IPD: |
Yes |
Plan Description: |
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 www.clinicalstudydatarequest.com. |
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Novartis ( Novartis Pharmaceuticals )
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Novartis Pharmaceuticals
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Not Provided
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Not Provided
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Novartis
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June 2021
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