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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002503-17 | EudraCT Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by intravitreal (IVT) injection.
Approximately 566 subjects will be randomized in approximately 126 global sites.
This study consists of a screening period of up to 4 weeks, after which subjects will receive investigational product for 48 weeks, followed by a safety follow-up period to week 52, for a total study duration of up to 56 weeks.
Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by IVT injection.
At week 8, subjects will be assessed for the primary endpoint. The primary endpoint is the change in Best Corrected Visual Acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline to week 8, in order to assess the efficacy of ABP 938 compared to aflibercept.
Subjects will then be re-randomized at week 16 in a masked fashion such that:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABP 938-Treatment Group A | Experimental | Subjects will receive 2 mg (0.05 mL) of ABP 938 by intravitreal (IVT) injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8) and every 8 weeks from week 16 until week 48. |
|
| Aflibercept-Treatment Group B1 | Active Comparator | Subjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive aflibercept by IVT injection every 8 weeks from week 16 until week 48. |
|
| ABP 938-Treatment group B2 | Active Comparator | Subjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive ABP 938 by IVT injection every 8 weeks from week 16 until week 48 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP 938 | Drug | Subject will receive ABP 938 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in BCVA at Week 8 | BCVA score was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Maintained Vision at Week 52 | A participant was classified as maintaining vision if he/she lost fewer than 15 letters in ETDRS letter score, assessed in the study eye, compared to Baseline. | Week 52 |
| Mean Change From Baseline in BCVA |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects are excluded if they meet any of the following criteria in the study eye:
Subjects are excluded if they meet any of the following criteria in either eye:
Other Medical Conditions
• Active extraocular infection or history of extraocular infections as follows: A. any active infection for which systemic anti-infectives were used within 4 weeks before randomization B. recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject
Washouts and Nonpermitted Treatments
General
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants, Ltd. - Research | Phoenix | Arizona | 85020 | United States | ||
| Retina Consultants of Orange County |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41857488 | Derived | Chow V, Zhou M, Mytych DT, Colbert A, Miller MJ, Wala I, Sabet A, Radziszewski W. Pharmacokinetic, Safety, and Immunogenicity Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501, Adalimumab-Atto. Pharmacol Res Perspect. 2026 Apr;14(2):e70236. doi: 10.1002/prp2.70236. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Both eyes were assessed at the screening visit for eligibility, and only 1 eye was selected from each participant as the study eye. If both eyes met the eligibility criteria, the study eye was the one with the worse best corrected visual acuity (BCVA).
This study was conducted at 102 centers in Canada, Czech Republic, Estonia, Germany, Hong Kong, Hungary, Israel, Italy, Japan, South Korea, Latvia, Lithuania, Poland, Slovakia, Spain, and the United States between 22 June 2020 and 30 January 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABP 938 / ABP 938 | Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by intravitreal (IVT) injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Through Week 16 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2022 | Dec 14, 2023 |
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The study is double-masked; therefore, the investigators, study personnel, and the study subjects will remain masked to treatment allocation. Unmasking is only allowed in the case of an emergency, when knowledge of the investigational product is essential for the clinical management of the subject.
| Aflibercept | Drug | Subject will receive aflibercept 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks |
|
|
BCVA score was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value. |
| Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52 |
| Percentage of Participants Who Gained at Least 10 Letters of Vision at Week 8 | Percentage of participants who gained at least 10 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. | Week 8 |
| Percentage of Participants Who Gained at Least 15 Letters of Vision at Week 52 | Percentage of participants who gained at least 15 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. | Week 52 |
| Mean Change From Baseline in Choroidal Neovascularization (CNV) Area Size | CNV area size was measured by fluorescein angiography. Change from Baseline calculated as observed post-baseline value - Baseline value. | Baseline and Weeks 8, 16, 24, and 52 |
| Mean Change From Baseline in Central Subfield Thickness (CST) | CST was defined as the average thickness in the ETDRS central 1 mm diameter subfield (the central subfield) and was measured by spectral domain optical coherence tomography. Change from Baseline calculated as observed post-baseline value - Baseline value. | Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical trial participant. TEAEs were defined as those AEs that begin or increase in severity or frequency at or after the time of first treatment to the End of Study visit. Events of interest (EOIs) pre-specified for this study included endophthalmitis, retinal detachment, increase in intraocular pressure, and thromboembolic events. Serious AEs were defined as any untoward medical occurrence that meets at least 1 of the following serious criteria:
| Up to Week 52 |
| Number of Participants Developing Binding Antidrug Antibodies (ADAs) | Number of participants with positive post-baseline ADA result through Week 16 and post Week 16 with negative or no result at Baseline is reported. | Baseline up to Week 52 |
| Fullerton |
| California |
| 92835 |
| United States |
| UCSD Shiley Eye Institute, Jacobs Retina Center | La Jolla | California | 92093 | United States |
| Jules Stein Eye Institute, UCLA | Los Angeles | California | 90095-7000 | United States |
| Southern California Desert Retina Consultants | Palm Desert | California | 92211 | United States |
| Retina Consultants San Diego | Poway | California | 92064 | United States |
| Retina Consultants of Southern California | Redlands | California | 92374 | United States |
| Retinal Consultants Medical Group, Inc. | Sacramento | California | 95825 | United States |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | United States |
| Miramar Eye Specialists | Ventura | California | 93003 | United States |
| Colorado Retina Associates | Lakewood | Colorado | 80228 | United States |
| Retina Group of New England | Waterford | Connecticut | 06385 | United States |
| Florida Retina Consultants | Lakeland | Florida | 33805 | United States |
| Medeye Associates | Miami | Florida | 33143 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| Georgia Retina, P.C. | Marietta | Georgia | 30060 | United States |
| Retina Associates IL | Elmhurst | Illinois | 60126 | United States |
| Sabates Eye Center | Leawood | Kansas | 66211 | United States |
| Retina Associates New Orleans | Metairie | Louisiana | 70006 | United States |
| The Retina Care Center | Baltimore | Maryland | 21209 | United States |
| Specialty Eye Institute | Jackson | Michigan | 49202 | United States |
| Retina Center | Saint Louis Park | Minnesota | 55416 | United States |
| Retina Vitreous Surgeons of Central NY, PC | Liverpool | New York | 13088 | United States |
| Macula Care | New York | New York | 10021 | United States |
| Ophthalmic Consultants of the Capital Region - Ophthalmology | Troy | New York | 12180 | United States |
| Charlotte Eye Ear Nose & Throat Associates, P.A. | Charlotte | North Carolina | 28210 | United States |
| Sterling Research Group | Cincinnati | Ohio | 45219 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Charleston Neuroscience Institute | Ladson | South Carolina | 29456 | United States |
| Black Hills Regional Eye Institute - Ophthalmology | Rapid City | South Dakota | 57701 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Retina Consultants of Texas Research Centers | Bellaire | Texas | 77401 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Texas Retina Associates | Fort Worth | Texas | 76012 | United States |
| Texas Retina Associates | Fort Worth | Texas | 76014 | United States |
| Ophthalmology Associates | Fort Worth | Texas | 76102 | United States |
| Premiere Retina Specialists | Midland | Texas | 79706 | United States |
| Retina Associates of South Texas, P.A. | San Antonio | Texas | 78240-1375 | United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| Strategic Clinical Research | Willow Park | Texas | 76087 | United States |
| University of Ottawa Eye Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Clinique d'ophtalmologie des laurentides | Boisbriand | Quebec | J7H 0E8 | Canada |
| Ocni klinika Pardubice | Pardubice | 530 02 | Czechia |
| FN Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Axon Clinical, s.r.o. | Prague | 150 00 | Czechia |
| Krajska zdravotni, a.s. Masarykova nemocnice v Usti n/ Labem | Ústí nad Labem | Ústí Nad Labem | 401 13 | Czechia |
| East Tallinn Central Hospital - Eye Clinic | Tallinn | Harju | 10138 | Estonia |
| Eye Clinic of Dr. Krista Turman | Tallinn | Harju | 11314 | Estonia |
| Silmalaser OÜ | Tallinn | Harju | 11412 | Estonia |
| Eye Clinic of Tartu University Hospital | Tartu | Tartu | 50406 | Estonia |
| University Medical Center Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Klinikum Darmstadt | Darmstadt | Hesse | 64283 | Germany |
| Universitätsmedizin Göttingen | Göttingen | Lower Saxony | 37075 | Germany |
| St. Franziskus Hospital Münster | Münster | North Rhine-Westphalia | 48145 | Germany |
| Universitätsmedizin Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Charité Universitätsmedizin Berlin KöR | Berlin | 12203 | Germany |
| University Hospital Of Leipzig | Leipzig | 04103 | Germany |
| The University of Hong Kong - Department of Ophthalmology | Aberdeen | 000000 | Hong Kong |
| Prince of Wales Hospital - Department of Ophthalmology and Visual Sciences | Shatin, New Territories | 000000 | Hong Kong |
| Ganglion Orvosi Központ | Pécs | Baranya | 7621 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo | Szeged | Csongrád megye | 6720 | Hungary |
| Debreceni Egyetem Klinikai Központ | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Péterfy Kórház-Rendelintézet és Manninger Jen Országos Traumatológiai Intézet - Szemészeti Osztály | Budapest | 1076 | Hungary |
| Bajcsy-Zsilinszky Kórház és Rendelintézet | Budapest | 1106 | Hungary |
| Budapest Retina Intezet | Budapest | 1133 | Hungary |
| MH Egészségügyi Központ | Budapest | H-1062 | Hungary |
| Semmelweis Egyetem | Budapest | H-1083 | Hungary |
| Meir Medical Center | Kfar Saba | Central District | 4428164 | Israel |
| Soroka University Medical Center | Beersheba | Southern District | 8410101 | Israel |
| Bnai Zion Medical Center | Haifa | Southern District | 3104802 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Assaf Harofeh Medical Center | Ẕerifin | 7030000 | Israel |
| Fondazione PTV Policlinico Tor Vergata, UNIT Patologie Retiniche | Rome | Lazio | 00133 | Italy |
| UOC Oculistica Fondazione PU A.Gemelli IRCCS Un.Cattolica del Sacro Cuore | Rome | Lazio | 00168 | Italy |
| Università degli Studi di Perugia, Ospedale Santa Maria della Misericordia, Clinica Oculistica | Perugia | Umbria | 06129 | Italy |
| UO Oftalmologia Ciardella Pol. S.Orsola Malpighi AOU di Bologna | Bologna | 40138 | Italy |
| "Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Oculistica Dipartimento di Chirurgia" | Milan | 20122 | Italy |
| Nagoya University Hospital | Nagoya | Aiti | 466-8560 | Japan |
| Nagoya City University Hospital - Ophthalmology | Nagoya | Aiti | 467-8602 | Japan |
| Nagoya University Hospital | Nagoya | Aiti | Japan |
| Asahikawa Medical University Hospital | Asahikawa | Hokkaidô | 078-8510 | Japan |
| Fukushima Medical University Hospital - Ophthalmology | Fukushima | Hukusima | 960-1295 | Japan |
| Kagoshima University Hospital - Ophthalmology | Kagoshima | Kagoshima-ken | 890-8520 | Japan |
| Mie University Hospital | Tsu | Mie-ken | 514-8507 | Japan |
| Nihon University Hospital - Ophthalmology | Tokyo | Tôkyô | 101-8309 | Japan |
| University of Yamanashi Hospital | Chūō | Yamanashi | 409-3898 | Japan |
| Akita University Hospital - Ophthalmology | Akita | 010-8543 | Japan |
| Nagasaki University Hospital - Ophthalmology | Nagasaki | 852-8501 | Japan |
| Kansai Medical University Hospital - Ophthalmology | Hirakata | Ôsaka | 573-1191 | Japan |
| P.Stradina Clinical University Hospital | Riga | Rga | 1002 | Latvia |
| Signes Ozolinas Doctor Praxis in Ophthalmology | Jelgava | LV- 3001 | Latvia |
| Klaipedos Universitetine ligoniene | Klaipėda | Klaipdos Apskritis | LT-92288 | Lithuania |
| Vilniaus Universiteto Ligonines Santariskiu Klinikos (VULSK) | Vilnius | Vilnius County | 8661 | Lithuania |
| Asociación para Evitar la Ceguera en México I.A.P. | México DF | Mexico City | 04030 | Mexico |
| Centro Medico Zambrano Hellion | Monterrey | Nuevo León | 64710 | Mexico |
| Centro de Retina Medica y Quirurgica S.C. | Zapopan | 45116 | Mexico |
| Szpital Sw. Wojciecha | Poznan | Greater Poland Voivodeship | 61-144 | Poland |
| Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM | Gdansk | Pomeranian Voivodeship | 80-809 | Poland |
| Centrum Medyczne PROMED | Krakow | 31-411 | Poland |
| Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o. | Olsztyn | 10-424 | Poland |
| Centrum Medyczne UNO-MED | Tarnów | 33-100 | Poland |
| Klinika Okulistyczna "Jasne Blonia" | Lodz | Ódzkie | 91-134 | Poland |
| Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Univerzitna nemocnica Bratislava | Bratislava | Bratislava Region | 851 07 | Slovakia |
| Fakultna nemocnica s poliklinikou Zilina | Žilina | Ilinský Kraj | 012 07 | Slovakia |
| Fakultna nemocnica Trencin | Trenčín | Treniansky Kraj | 911 71 | Slovakia |
| Asan Medical Center | Seoul | Seoul Teugbyeolsi | 05505 | South Korea |
| Samsung Medical Center - Ophthalmology | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital - Neurology | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| Seoul National University Hospital - Department of Ophthalmology | Seoul | Seoul Teugbyeolsi | 3080 | South Korea |
| Korea University Anam Hospital - Ophthalmology | Seoul | 02841 | South Korea |
| Hospital Universitario de Bellvitge | LHospitalet de Llobregat | Barcelona | 8097 | Spain |
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| FISABIO - Oftalmología Médica | Valencia | 46015 | Spain |
| Aflibercept / Aflibercept |
Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to remain on aflibercept dosing every 8 weeks from Week 16 until Week 48. |
| FG002 | Aflibercept / ABP 938 | Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. |
| COMPLETED | Completed through Week 16 |
|
| NOT COMPLETED |
|
|
| Post Week 16 |
|
|
Full Analysis Set: Consisted of all randomized participants, with treatment as the randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were initially randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABP 938 | Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48. |
| BG001 | Aflibercept | Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in BCVA at Week 8 | BCVA score was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value. | Full Analysis Set: Consisted of all randomized participants, with treatment as the randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were initially randomized. Analysis included participants with available data at Baseline and Week 8. | Posted | Mean | Standard Deviation | Letters | Baseline and Week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Maintained Vision at Week 52 | A participant was classified as maintaining vision if he/she lost fewer than 15 letters in ETDRS letter score, assessed in the study eye, compared to Baseline. | Full Analysis Set (Re-randomized): Consisted of all re-randomized participants, with treatment as the randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and Week 52. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in BCVA | BCVA score was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value. | Full Analysis Set (Re-randomized): Consisted of all randomized participants, with treatment as the re-randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and at each timepoint. | Posted | Mean | Standard Deviation | Letters | Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Gained at Least 10 Letters of Vision at Week 8 | Percentage of participants who gained at least 10 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. | Full Analysis Set: Consisted of all randomized participants, with treatment as the randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were initially randomized. Analysis included participants with available data at Baseline and Week 8. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Gained at Least 15 Letters of Vision at Week 52 | Percentage of participants who gained at least 15 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. | Full Analysis Set (Re-randomized): Consisted of all re-randomized participants, with treatment as the randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and Week 52. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Choroidal Neovascularization (CNV) Area Size | CNV area size was measured by fluorescein angiography. Change from Baseline calculated as observed post-baseline value - Baseline value. | Full Analysis Set (Re-randomized): Consisted of all randomized participants, with treatment as the re-randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and at each timepoint. | Posted | Mean | Standard Deviation | mm^2 | Baseline and Weeks 8, 16, 24, and 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Central Subfield Thickness (CST) | CST was defined as the average thickness in the ETDRS central 1 mm diameter subfield (the central subfield) and was measured by spectral domain optical coherence tomography. Change from Baseline calculated as observed post-baseline value - Baseline value. | Full Analysis Set (Re-randomized): Consisted of all randomized participants, with treatment as the re-randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and at each timepoint. | Posted | Mean | Standard Deviation | μm | Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical trial participant. TEAEs were defined as those AEs that begin or increase in severity or frequency at or after the time of first treatment to the End of Study visit. Events of interest (EOIs) pre-specified for this study included endophthalmitis, retinal detachment, increase in intraocular pressure, and thromboembolic events. Serious AEs were defined as any untoward medical occurrence that meets at least 1 of the following serious criteria:
| Safety Analysis Set: Consisted of all participants who received at least 1 dose of investigational product, with treatment assignment based on actual treatment received. TEAEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16. | Posted | Count of Participants | Participants | Up to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Developing Binding Antidrug Antibodies (ADAs) | Number of participants with positive post-baseline ADA result through Week 16 and post Week 16 with negative or no result at Baseline is reported. | Safety Analysis Set (Re-randomized and Treated): Consisted of all participants who received at least 1 dose of investigational product, with treatment assignment based on actual treatment received. Analysis included participants with available data at Baseline and at each timepoint. | Posted | Count of Participants | Participants | Baseline up to Week 52 |
|
Up to Week 52
All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Through Week 16: ABP 938 | Participants were treated with 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8). | 0 | 288 | 6 | 288 | 18 | 288 |
| EG001 | Through Week 16: Aflibercept | Participants were treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8). | 2 | 288 | 9 | 288 | 15 | 288 |
| EG002 | Post Week 16: ABP 938 / ABP 938 | Participants who were initially treated with ABP 938 and remained on treatment with 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. | 2 | 273 | 22 | 273 | 20 | 273 |
| EG003 | Post Week 16: Aflibercept / ABP 938 | Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. | 2 | 133 | 14 | 133 | 17 | 133 |
| EG004 | Post Week 16: Aflibercept / Aflibercept | Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. | 0 | 136 | 11 | 136 | 17 | 136 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Adrenal haematoma | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Arthropod-borne disease | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Rosai-Dorfman syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Transitional cell cancer of the renal pelvis and ureter | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bladder neck obstruction | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Subclavian artery stenosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neovascular age-related macular degeneration | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2022 | Dec 14, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| Consent Withdrawn |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Requirement for Alternative Therapy |
|
| Requirement for Alternative Dosing Schedule |
|
| Miscellaneous |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Multiple |
|
| White |
|
Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. |
|
|
|
| OG002 | Aflibercept / ABP 938 | Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG002 |
| Aflibercept / ABP 938 |
Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. |
|
|
|
Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. |
|
|
|
| OG002 |
| Aflibercept / ABP 938 |
Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. |
|
|
|
Participants were treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8).
| OG002 | Post Week 16: ABP 938 / ABP 938 | Participants who were initially treated with ABP 938 and remained on treatment with 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. |
| OG003 | Post Week 16: Aflibercept / ABP 938 | Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. |
| OG004 | Post Week 16: Aflibercept / Aflibercept | Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. |
|
|
| OG003 | Post Week 16: Aflibercept / ABP 938 | Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. |
| OG004 | Post Week 16: Aflibercept / Aflibercept | Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48. |
|
|