Neovascular Age-Related Macular DegenerationPhase 3PULSARNCT04423718
Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye
A Phase 3 study testing Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) and Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321) in people with Neovascular Age-Related Macular Degeneration, run by Bayer at 235 sites in 27 countries.
Trial summary
In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). 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?
- Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) and Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,011 participants
- Where
- 235 sitesin 27 countries
- Study dates
- 11 Aug 2020to 7 Aug 2024
- Phase
- Phase 3
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
- Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
- Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
- BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
- Decrease in BCVA determined to be primarily the result of nAMD in the study eye.
- Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.
Show all 10Show fewer
- Other protocol-specified inclusion criteria.
- Additional inclusion criteria for Year 3:
- At least one BCVA value and one central subfield retinal thickness (CST) value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92).
- Participant is enrolled at a site that participates in the extension period.
Who cannot join
- Causes of CNV other than nAMD in the study eye.
- Scar, fibrosis, or atrophy involving the central subfield in the study eye.
- Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye.
- Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
- History of idiopathic or autoimmune uveitis in the study eye.
- Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
Show all 11Show fewer
- History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye.
- Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.
- Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg).
- Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins.
- Other protocol-specified exclusion criteria
Trial locations and contacts
235 sites in 27 countries.
235 sites in 27 countries
United States57 sites
Retina Consultants of Hawaii - Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Eye Associates of New Mexico - Albuquerque - Retina Center
Albuquerque, New Mexico, 87109
Austin Retina Associates - Central
Austin, Texas, 78705
The Retina Care Center - Baltimore
Baltimore, Maryland, 21209
Mid Atlantic Retina - Philadelphia / Wills Eye Hospital
Bethlehem, Pennsylvania, 18017
Retina Center of New Jersey
Bloomfield, New Jersey, 07003
Ophthalmic Consultants of Boston - Boston
Boston, Massachusetts, 02114
The University of Vermont Medical Center (Fletcher Allen Health Care) - Main Campus
Burlington, Vermont, 05401-1473
Charleston Neuroscience Institute - Charleston
Charleston, South Carolina, 29414
Retina Consultants of Southern Colorado, PC
Colorado Springs, Colorado, 80909
Rand Eye Institute
Deerfield Beach, Florida, 33064
Midwest Retina - Main Office
Dublin, Ohio, 43016
Vitreo Retinal Surgery PA - Edina
Edina, Minnesota, 55435
NJ Retina - Edison Office
Edison, New Jersey, 08820
Retina Associates IL
Elmhurst, Illinois, 60126
Erie Retinal Research
Erie, Pennsylvania, 16507
Retina Group of Florida - Fort Lauderdale
Fort Lauderdale, Florida, 33308
Texas Retina Associates - Fort Worth
Fort Worth, Texas, 76104
Retina Consultants of Orange County - Fullerton
Fullerton, California, 92835
Vitreo Retinal Associates PA - The Millennium Center Location
Gainesville, Florida, 32607-2557
Long Island Vitreoretinal Consultants - Great Neck
Great Neck, New York, 11021
Vitreoretinal Consultants of NY - Hauppauge
Hauppauge, New York, 11788
Florida Retina Institute- Jacksonville Oak
Jacksonville, Florida, 32204
Eye Care Specialists - Kingston, PA
Kingston, Pennsylvania, 18704
Retina Consultants of Nevada - Summerlin
Las Vegas, Nevada, 89144
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Florida Eye Associates - Melbourne Main Office
Melbourne, Florida, 32901
Charles Retina Specialists - Germantown
Memphis, Tennessee, 38119
Retina Macula Specialists Of Miami - LeJeune Road Office
Miami, Florida, 33126
West Virginia University
Morgantown, West Virginia, 26505
Northern California Retina Vitreous Associates - Mountain View Office
Mountain View, California, 94040
Vanderbilt University Medical School
Nashville, Tennessee, 37212-1610
New England Retina Associates
New London, Connecticut, 06320
University Retina and Macula Associates
Oak Forest, Illinois, 60452
Florida Retina Institute - Orlando
Orlando, Florida, 32806
Azul Vision Pasadena
Pasadena, California, 91107
Retina Specialty Institute - Pensacola
Pensacola, Florida, 32503
Arizona Retina & Vitreous Consultants - Central Phoenix Phoenix
Phoenix, Arizona, 85021-8865
Retina Northwest - NW Lovejoy
Portland, Oregon, 97210
Retina Consultants San Diego - Poway
Poway, California, 92064
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Retina Consultants of Southern California
Redlands, California, 92374
Kaiser Permanente Riverside Medical Center - Cardiology
Riverside, California, 92505
Retina Consultants, LLC
Salem, Oregon, 97302
Medical Center Ophthalmology Associates - Northwest
San Antonio, Texas, 78240
Retina Consultants of Texas - San Antonio Medical Center
San Antonio, Texas, 78240
Perlman Medical Offices at UC San Diego Health - Endocrinology
San Diego, California, 92037
Spokane Eye Clinical Research
Spokane, Washington, 99204
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, 33711
Southern Vitreoretinal Associates, P.L. - Tallahassee
Tallahassee, Florida, 32308
Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
The Woodlands, Texas, 77384
Retina Consultants of Texas - The Woodlands
The Woodlands, Texas, 77384
Ophthalmic Consultants of the Capital Region - Troy
Troy, New York, 12180
Palmetto Retina Center - West Columbia
West Columbia, South Carolina, 29169
Wolfe Eye Clinic - Des Moines
West Des Moines, Iowa, 50266-7705
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Japan49 sites
Akita University Hospital
Akita, 010-8543
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, 660-8550
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898
St.Luke's International Hospital
Chuoku, Tokyo, 104-8560
Nishikasai Inouye Eye Hospital
Edogawa-ku, Tokyo, 134-0088
Hayashi Eye Hospital
Fukuoka, 812-0011
Fukushima Medical University Hospital
Fukushima, 960-1295
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, 193-0998
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
Hiroshima University Hospital
Hiroshima, 734-8551
Daiyukai Daiichi Hospital
Ichinomiya, Aichi-ken, 491-8551
Tokiwadai Muranaka Eye Clinic
Itabashi-ku, Tokyo, 174-0071
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, 920-0293
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
Nara Medical University Hospital
Kashihara, Nara, 634-8522
Medical corporation Eiwakai Dannoue Ophthalmology clinic
Kawasaki, Kanagawa, 211-0053
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Southern Tohoku Eye Clinic
Kōriyama, Fukushima, 963-8052
Kurashiki Medical Center
Kurashiki, Okayama-ken, 710-8522
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Gunma University Hospital
Maebashi, Gunma, 371-8511
Shinshu University Hospital
Matsumoto, Nagano, 390-8621
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902
Kozawa Eye Hospital and Diabetes Center
Mito, Ibaraki, 310-0845
University of Miyazaki Hospital
Miyazaki, 889-1692
Kansai Medical University Medical Center
Moriguchi, Osaka, 570-8507
Aichi Medical University Hospital
Nagakute, Aichi-ken, 480-1195
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, 852-8511
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
University of the Ryukyus Hospital
Nakagami, Okinawa, 903-0215
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511
Japanese Red Cross Saitama Hospital
Saitama, 330-8553
Sapporo City General Hospital
Sapporo, Hokkaido, 060-8604
KKR Sapporo Medical Center
Sapporo, Hokkaido, 062-0931
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
Tokushima University Hospital
Tokushima, 770-8503
Mie University Hospital
Tsu, Mie-ken, 514-8507
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505
Japanese Red Cross Wakayama Medical center
Wakayama, 640-9558
Yamagata University Hospital
Yamagata, 990-9585
Otakeganka Tsukimino Clinic
Yamato, Kanagawa, 242-0001
Oita University Hospital
Yufu, Oita Prefecture, 879-5593
China31 sites
Beijing Hospital
Beijing, Beijing Municipality, 100730
Beijing Tongren Hospital, Capital Medical University (East)
Beijing, Dongcheng District, 100005
Beijing Aier Intech Eye Hospital
Beijing, 100000
Peking University People's Hospital
Beijing, 100032
Eye Center of the second Bethune Hospital, jinlin University
Changchun, Jilin, 130022
Aier Eye Hospital (Chengdu)
Chengdu, Sichuan
Chongqing Aier Ophthalmology Hospital
Chongqing, 400020
The 1st Affiliated Hospital Fujian Medical University
Fuzhou, Fujian, TBC
Guangzhou Aier Eye Hospital
Guangzhou, Guangdong, 634050
The 1st Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
ZheJiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Hebei eye hospital
Hebei, Hebei, 050010
The Second Hospital of Anhui medical university
Hefei, Anhui, 230601
Henan Provincial Eye Hospital
Henan, Henan, 450008
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006
People's Hospital of Ningxia Hui Autonomous Region - Opthalmology
Ningxia, Ningxia, 750002
Shanghai Tongji Hospital of Tongji University
Shanghai, 200065
Shanghai General Hospital
Shanghai, 200080
Shenyang He Eye Specialist Hospital
Shenyang, Liaoning, 110034
Shijiazhuang General Hospital
Shijiazhuang, Hebei, 50000
Tianjin Medical University General Hospital
Tianjin, 300052
Tianjin Eye Hospital
Tianjin, 300384
Tianjin Medical University Eye Hospital
Tianjin, 300384
Tonghua Central Hospital
Tonghua, Jilin, 134001
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
The Affiliated Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 0
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Wuhan, Hubei, 430030
Union Hospt Tongji Medical Colleg. Huazhong univ. Scien&Tech
Wuhan, Hubei, 430030
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
The First People's Hospital of Xuzhou
Xuzhou, Jiangsu, 221002
Czechia7 sites
Fakultní Nemocnice Hradec Kralové
Hradec Králové, 500 05
Fakultní nemocnice Ostrava
Ostrava, 708 52
Fakultni nemocnice Plzen - Lochotin
Plzen-Lochotin, 323 00
Fakultni nemocnice Kralovske Vinohrady
Prague, 10034
Charles University in Prague
Prague, 110 00
Lexum a.s., Evropska ocni klinika
Prague, 140 00
Axon Clinical, s.r.o.
Prague, 150 00
Israel7 sites
Rambam Health Corporation
Haifa, 3109601
Lady Davis Carmel Medical Center
Haifa, 3436212
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, 9112001
Meir Medical Center
Kfar Saba, 4428164
Chaim Sheba Medical Center
Ramat Gan, 5262000
Kaplan Medical Center
Rehovot, 7610001
Assuta Medical Centers - HaShalom
Tel Aviv, 6789140
Italy7 sites
Azienda Ospedaliero-Universitaria Di Cagliari
Cagliari, Sardinia, 9042
ASST Fatebenefratelli Sacco
Milan, Lombardy, 20122
Ospedale San Raffaele s.r.l. - Oculistica
Milan, Lombardy, 20132
A.O. di Perugia
Perugia, Umbria, 6129
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Rome, Lazio, 00133
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Rome, Lazio, 198
South Korea7 sites
Pusan National University Hospital
Busan, 49241
Inje University Haeundae Paik Hospital
Busan, 612-862
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620
Nune Eye Hospital - Retina Center Ophthalmology
Seoul, Gangnam-gu, 135-280
Asan Medical Center - Oncology Department
Seoul, Seoul Teugbyeolsi, 05505
Seoul National University Hospital (b)
Seoul, 03080
Samsung Medical Center - Oncology Department
Seoul, 06351
Spain7 sites
Hospital Clínic i Provincial de Barcelona
Barcelona, 8036
Hospital de la Santa Creu i Sant Pau | Gynecology Department
Barcelona, 8041
Hospital Universitario Reina Sofia - Oftalmologia
Córdoba, 14004
Instituto Oftalmologico Gomez-Ulla S.L. - Oftalmologia
Santiago de Compostela, A Coruña, 15706
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario Y Politecnico La Fe - Oftalmologia
Valencia, 46026
Hospital Universitario Miguel Servet - Oftalmologia
Zaragoza, 50009
Bulgaria6 sites
SEHAT Pentagram
Sofia, 1309
Spec. Hosp. for Active Treatment for Eye Diseases Zrenie
Sofia, 1408
University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
Sofia, 1431
Multiprofile Hospital for Active Treatment Sveta Sofia | Internal Diseases Department
Sofia, 1618
Specialized Hospital For Active Treatment of Eye Diseases Zora
Sofia, 1784
Sveta Petka Eye Hospital
Varna, 9000
Australia5 sites
Eyeclinic Albury Wodonga
Albury, New South Wales, 2640
Hobart Eye Surgeons
Hobart, Tasmania, 7000
Marsden Eye Surgery Center
Parramatta, New South Wales, 2150
Sydney Retina Clinic
Sydney, New South Wales, 2000
Westmead Hospital
Westmead, New South Wales, 2145
Austria5 sites
Medizinische Universität Graz
Graz, Styria, 8036
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, 9020
Kepler Universitätsklinikum Campus III
Linz, Upper Austria, 4020
Konventhospital Barmherzige Brüder Linz
Linz, Upper Austria, 4021
Hanusch-Krankenhaus Wien
Vienna, 1140
Portugal5 sites
AIBILI
Coimbra, 3000-548
Espaco Medico de Coimbra
Coimbra, 3000-548
ALM Oftalmolaser - Oftalmologia Medica e Cirurgica
Lisbon, Lisbon District, 1050-078
Centro Hospitalar Universitario do Porto
Porto, 4099-001
Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research Center
Porto, 4434-502
Georgia4 sites
LTD "Clinic LJ" - Opthalmology
Kutaisi, 4600
JSC "Evex Hospitals'
Tbilisi, 0186
LTD "Innova"
Tbilisi, 105
LTD "Chichua Medical Center MZERA"
Tbilisi, 114
Slovakia4 sites
Fakultna nemocnica Nitra
Nitra, 950 01
Nemocnica s Poliklinikou Trebisov, Svet zdravia a.s.
Trebišov, 075 01
Fakultna nemocnica Trencin
Trenčín, 911 71
Fakultna nemocnica s poliklinikou Zilina
Žilina, 012 07
Canada3 sites
Institut de l'Oeil des Laurentides
Boisbriand, Quebec, J7H1S6
St.Joseph's Health Care-London
London, Ontario, N6A 4V2
Toronto Retina Institute
Toronto, Ontario, M3C 0G9
France3 sites
Centre d'Ophtalmologie - Paradis-Monticelli
Marseille, 13008
AP-HP - Hopital Lariboisiere
Paris, 75475
Centre ophtalmologique Saint-Exupéry
Saint-Cyr-sur-Loire, 37540
Latvia3 sites
Department of Ophthalmology
Riga, 1002
Latvian American Eye Center
Riga, LV-1009
Riga East Clinical University Hospital "Gailezers"
Riga, LV-1038
Lithuania3 sites
Hospital of LT University of Health Sciences Kaunas Clinics
Kaunas, LT-50161
PI Klaipedos University Hospital
Klaipėda, LT-92288
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08661
Serbia3 sites
Clinical Center of Serbia
Belgrade, 11000
Clinical hospital center Zvezdara
Belgrade, 11000
Klinicki centar Vojvodine
Novi Sad, 21000
Switzerland3 sites
Berner Augenklinik am Lindenhofspital
Bern, TBC
RétinElysée
Lausanne, Canton of Vaud, 1006
Stadtspital Triemli
Zurich, 8063
Taiwan3 sites
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Memorial Hospital at Linkou
Taoyuan, 33305
Ukraine3 sites
Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
Kropyvnytskyi, 25006
Centralna Polyclinica MVS Ukraiiny
Kyiv, 1024
Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
Poltava, 36011
Argentina2 sites
Organizacion Medica de Investigacion (OMI)
Buenos Aires, Ciudad Auton. de Buenos Aires, C1015ABO
OFTALMOS, Instituto Oftalmologico de Alta Complejidad
Buenos Aires, Ciudad Auton. de Buenos Aires, C1120AAN
Estonia2 sites
AS Ida-Tallinna Keskhaigla - Oftalmoloogiakeskus
Tallinn, 10138
Sihtasutus Tartu Ülikooli Kliinikum - Silmakliinik
Tartu, 50406
Hungary2 sites
Budapest Retina Associates
Budapest, 1133
Szent-Gyorgyi Albert Orvostudomanyi Egyetem
Szeged, 6720
Russia2 sites
Scientific Research Institution of Ophthalmic Diseases
Moscow, 119021
FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov
Moscow, 127486
Singapore2 sites
National University Hospital Medical Centre
Singapore, 119074
Singapore National Eye Centre
Singapore, 168751
About this study
Official title: Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.
- Being tested
- Aflibercept High Dose VEGF Trap-Eye (BAY86-5321), Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
- Keywords
- nAMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)Drug
Solution in Vial, intravitreal (IVT) injection
Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)Drug
Solution in Vial, 2 mg, intravitreal (IVT) injection
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept 2q8 | Active comparator | In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental) Receives: Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321); Drug: Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321) |
| Aflibercept HDq12 | Experimental | Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response. Receives: Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) |
| Aflibercept HDq16 | Experimental | Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response. Receives: Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
Measured: At baseline and Week 48
Secondary outcomes (11)
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
Measured: At baseline and Week 60
Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16
Measured: At Week 16
Percentage of Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 48
Measured: At baseline and Week 48
Percentage of Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 48
Measured: At Week 48
Change in Choroidal Neovascularization (CNV) Size From Baseline to Week 48
Measured: At baseline and Week 48
Change in Total Lesion Area From Baseline to Week 48
Measured: At baseline and Week 48
Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in the Center Subfield at Week 48
Measured: At Week 48
Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48
Measured: At baseline and Week 48
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48
NEI VFQ-25 was a 25-item questionnaire that gave a score on a scale from 0 (worst) to 100 (best = no vision problems)
Measured: At baseline and Week 48
Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Week 48
Measured: Up to Week 48
Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response
Measured: Up to week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start11 Aug 2020
- Primary completion27 Jul 2022
- Study completion7 Aug 2024
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423718
- Sponsor's protocol ID
- 20968
- Other IDs
- 2019-003851-12, 2019
- Acronym
- PULSAR
- Status last verified
- Aug 2025
- First submitted
- 8 Jun 2020
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Sun X, Dai H, Chen Y, Sun X, Tao L, Xiao J, Han M, Zhao M, Wang L, Schulze A, Schmidt-Ott UM, Zhao M, Zhang X, Wang Z, Leal S, Wei W; PULSAR investigators. Intravitreal aflibercept 8 mg in patients with neovascular age-related macular degeneration from China: 48-week results from the PULSAR trial. Int J Retina Vitreous. 2026 Jun 26. doi: 10.1186/s40942-026-00876-5. Online ahead of print.
PubMed 42363252Loewenstein A, Schmidt-Ott U, Do DV, Lanzetta P, Leal S, Berliner AJ, Chu KW, Barakat MR, Ghorayeb G, Stewart MW, Spitzer MS, Zhang X, McCullough A, Tueckmantel C, Avila D, Morgan-Warren P, Brunck L, Dupljak A, Hymowitz M, Portnoy A, Gale R. Intraocular Pressure Outcomes with Intravitreal Aflibercept 8 mg: A 96-Week Pooled Analysis from PULSAR and PHOTON. Ophthalmol Ther. 2026 Jul;15(7):2441-2456. doi: 10.1007/s40123-026-01424-y. Epub 2026 Jun 13.
PubMed 42287526Chang A, Sun X, Iida T, Lai TYY, Wong TY, Cheung CMG, Lee WK, Zhang X, Schulze A, Schmidt-Ott UM, Zhao M, Hasanbasic Z, Leal S, Chen SJ; PULSAR study investigators. Intravitreal aflibercept 8 mg versus 2 mg in Asian patients with neovascular age-related macular degeneration: 48-week analysis of the Phase 3 PULSAR trial. Asia Pac J Ophthalmol (Phila). 2026 Jan-Feb;15(1):100278. doi: 10.1016/j.apjo.2026.100278. Epub 2026 Jan 8.
PubMed 41519383Lee WK, Wong TY, Chen SJ, Sun X, Cheung CMG, Silva R, Ricci F, Zhang X, Machewitz T, Schulze A, Schmidt-Ott UM, Zhao M, Hasanbasic Z, Leal S, Iida T; PULSAR Study Investigators. Aflibercept 8 mg in Polypoidal Choroidal Vasculopathy: Post Hoc Analysis of the PULSAR Randomized Clinical Trial. JAMA Ophthalmol. 2026 Feb 1;144(2):129-137. doi: 10.1001/jamaophthalmol.2025.5098.
PubMed 41411005Korobelnik JF, Lanzetta P, Leal S, Holz FG, Clark WL, Eichenbaum D, Iida T, Sun X, Berliner AJ, Schulze A, Zhao M, Schmelter T, Schmidt-Ott U, Zhang X, Morgan-Warren P, Hasanbasic Z, Vitti R, Chu KW, Reed K, Bhore R, Cheng Y, Bai Z, Hirshberg B, Yancopoulos GD, Wong TY; PULSAR Investigators. Intravitreal Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration: Ninety-Six-Week Results from the Randomized Phase 3 PULSAR Trial. Ophthalmology. 2026 Jan;133(1):39-50. doi: 10.1016/j.ophtha.2025.08.022. Epub 2025 Aug 26.
PubMed 40876598Lanzetta P, Korobelnik JF, Heier JS, Leal S, Holz FG, Clark WL, Eichenbaum D, Iida T, Xiaodong S, Berliner AJ, Schulze A, Schmelter T, Schmidt-Ott U, Zhang X, Vitti R, Chu KW, Reed K, Rao R, Bhore R, Cheng Y, Sun W, Hirshberg B, Yancopoulos GD, Wong TY; PULSAR Investigators. Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial. Lancet. 2024 Mar 23;403(10432):1141-1152. doi: 10.1016/S0140-6736(24)00063-1. Epub 2024 Mar 7.
PubMed 38461841