Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

Macular Degeneration Clinical Trial

Official title:

Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (SEQUOIA Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462486
• Other study ID #: 150998-006
• Secondary ID: 2014-004580-20SE
• Status: Completed
• Phase: Phase 3
• Start date: June 25, 2015
• Est. completion date: June 6, 2019

Study information

• Verified date: July 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 949
• Est. completion date: June 6, 2019
• Est. primary completion date: April 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of age-related macular degeneration in at least 1 eye

• Best corrected visual acuity of 20/40 to 20/320 in the study eye

• Best corrected visual acuity of 20/200 or better in the non-study eye

Exclusion Criteria:

• History of vitrectomy, macular surgery, or glaucoma surgery in the study eye

• Cataract or refractive surgery in the study eye within the last 3 months

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Abicipar Pegol
Abicipar pegol intravitreal injection.
• Ranibizumab
Ranibizumab intravitreal injection.

Other:
• Sham Procedure
Sham injection.

Locations

Country	Name	City	State
Australia	Centre for Eye Research Australia	East Melbourne	Victoria
Australia	Specialist Eye Group	Glen Waverley	Victoria
Australia	Lions Eye Institute	Nedlands	Western Australia
Australia	Save Sight Institute, University of Sydney Eye Hospital	Sydney	New South Wales
Australia	Sydney Retina Clinic and Day Surgery	Sydney	New South Wales
Australia	Sydney West Retina	Westmead	New South Wales
Brazil	Instistuto da Visao - Hospital de Olhos Ltda	Belo Horizonte	Minas Gerais
Brazil	Centro Brasileiro de Cirurgia de Olhos - CBCO	Goiania	Goias
Brazil	Clinica de Olhos Dr. Suel Abujamra	Sao Paulo
Brazil	Instituto Da Visao UNIFESP EPM (Universidade Federal de Sao Paulo - Escola Paulista de Medicina)	Sao Paulo
Brazil	Hospital Oftalmologico de Sorocaba	Sorocaba	Sao Paulo
Canada	Calgary Retina Consultants	Calgary	Alberta
Canada	St Joseph's Health Care London - Ivey Eye Institute	London	Ontario
Canada	Canadian Centre for Advanced Eye Therapeutics Inc	Mississauga	Ontario
Canada	University of Ottawa Eye Institute	Ottawa	Ontario
Canada	Toronto Retina Institute	Toronto	Ontario
Denmark	Rigshospitalet-Glostrup	Glostrup	Hovedstaden
Denmark	Odense University Hospital	Odense	Syddanmark
Hungary	Bajcsy-Zsilinszky Hospital	Budapest
Hungary	Budapest Retina Associates Kft.	Budapest
Hungary	Magyar Honvedseg Egeszegugyi Kozpont	Budapest
Hungary	Semmelweis University	Budapest
Hungary	Szent Imre Teaching Hospital	Budapest
Hungary	University of Debrecen, Medical Center	Debrecen
Hungary	Ganglion Medical Centre	Pecs
Hungary	University of Szeged	Szeged
Hungary	Markusovszki Teaching Hospital	Szombathely
Italy	A.O.U. Policlinico Sant Orsola Malpighi Pad1, 4Piano, Studio Medici via Pelagio Palagi 9	Bologna
Italy	Ospedale Clinicizzato	Chieti	Abruzzi
Italy	Azienda Ospedaliero-Universitaria Careggi - SOD Oculistica, Dipartimento di Chirurgia e Medicina Traslazionale	Firenze	Tuscany
Italy	Clinica Oculistica DINOGMI Universita di Genova	Genova
Italy	Clinica Oculistica- Dipartimento di Scienze Cliniche Universita di Milano	Milan	Lombardy
Italy	Eye Clinic - Fondazione IRCCS	Milan	Lombardy
Italy	IRCCS Ospedale San Raffaele	Milano
Italy	Azienda Universitaria Ospedaliera Pisana, Ospedale "Nuovo S.Chiara" Cisanello	Pisa	Tuscany
Italy	Fondazione G.B. Bietti-IRCCS	Roma
Italy	Policlinico Agostino Gemelli	Roma
Italy	Ospedale Molinette	Torino	Piedmont
Italy	Clinica Oculistica, Ospedale Santa Maria della Misericordia	Udine	Friuli-Venezia Giulia
Italy	IRCCS - Istuto di Recovero e Cura a Carattere Scientifico	Verona	Vento
Japan	Hyogo Prefectural Amagasaki Hospital General Medical Center	Amagasaki	Hyogo
Japan	Nihon University Hospital	Chiyoda	Tokyo
Japan	Chofu Eye Clinic	Chofu	Tokyo
Japan	Kyushu University Hospital	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Tokyo Medical University Hachioji Medical Center	Hachioji	Tokyo
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka
Japan	Iida Municipal Hospital	Iida	Nagano
Japan	Tokyo Medical University Ibaraki Medical Center	Inashiki	Ibaraki
Japan	Kameda Clinic	Kamogawa	Chiba
Japan	Kikuna Yuda Eye Clinic	Kanagawa	Kanto
Japan	Kokura Kinen Hospital	Kitakyushu
Japan	Ideta Eye Hospital	Kumamoto
Japan	Kimura Eye And Internal Medicine Hospital	Kure	Hiroshima
Japan	Mito Kyodo General Hospital	Mito	Ibaraki
Japan	Aichi Medical University Hospital	Nagakute	Aichi
Japan	The Japanese Red Cross Nagasaki Genbaku Hospital	Nagasaki
Japan	Japan Community Health Care Organization Chukyo Hospital	Nagoya	Aichi
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Nara Medical University Hospital	Nara
Japan	Ogaki Tokushukai Hospital	Ogaki	Gifu
Japan	Medical Corporation Jinshikai Nishi Eye Hospital	Osaka
Japan	Musashi Dream Clinic	Osaka
Japan	Tane Memorial Eye Hospital	Osaka
Japan	Shiga University of Medical Science Hospital	Otsu	Shiga
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Sapporo City General Hospital	Sapporo	Hokkaido
Japan	Takeuchi Eye Clinic	Taito	Tokyo
Japan	Tokyo Women's Medical University Hospital	Tokyo
Japan	Mie University Hospital	Tsu	Mie
Japan	Juntendo University Urayasu Hospital	Urayasu	Chiba
Japan	Otakeganka Tsukimino Clinic	Yamato	Kanagawa
Netherlands	Academic Medical Center	Amsterdam	North Holland
Netherlands	Leiden University Medical Center	Leiden	South Holland
Netherlands	Oogziekenhuis Rotterdam	Rotterdam	North Holland
Netherlands	Elisabeth Hospital	Tilburg	North Brabant
Peru	Macula D&T Eye Center	San Isidro	Lima
Poland	Optimum Profesorskie Centrum Okulistyki	Gdansk
Poland	Klinika Okulistyczna Jasne Blonia	Lodz
Poland	Centrum Diagnostyki i Mikrochirurgii	Olsztyn
Poland	Retina Eye Hospital	Warsaw
Poland	Uniwersytecki Szpital Kliniczny	Wroclaw
Russian Federation	S. Fyodorov Eye Microsurgery Federal State Institution	Moscow
Russian Federation	Scientific Research Institute of Ocular Diseases of RAMS	Moscow
South Africa	Pasteur Medical Centre	Bloemfontein
South Africa	Dr Actons Privat Practice	Cape Town
South Africa	Pretoria Eye Institute, Private Practice	Pretoria
Taiwan	Department of Ophthalmology Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Department of Ophthalmology National Taiwan University Hospital	Taipei
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei
Taiwan	Chang Gung Medical Foundation, Linkou Branch	Taoyuan
Turkey	Ankara Uni Med Fac	Ankara
Turkey	Dokuz Eylul Uni Med Fac	Izmir
United Kingdom	Barnet Hospital	Barnet
United Kingdom	Bradford Royal Infirmary (BRI)	Bradford	West Yorkshire
United Kingdom	Bristol Eye Hospital	Bristol
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	ESNEFT Essex County Hospital	Colchester	Essex
United Kingdom	Royal Derby Hospital	Derby	Derbyshire
United Kingdom	Frimley Park Hospital	Frimley	Camberley
United Kingdom	Royal Surrey Hospital	Guildford	South East
United Kingdom	Royal Liverpool University Hospital	Liverpool	North West England
United Kingdom	University Hospital Aintree	Liverpool
United Kingdom	Barnet Royal Free Hospital	London
United Kingdom	King's College Hospital	London
United Kingdom	Moorfields Eye Hospital	London
United Kingdom	Royal Victoria Infirmary	Newcastle
United Kingdom	Oxford Eye Hospital, John Radcliffe Hospital	Oxford	Headington
United Kingdom	Hospital of St. Cross	Rugby
United Kingdom	Sheffield Teaching Hospitals	Sheffield	Yorkshire
United Kingdom	University Hospital Southampton	Southampton	Hampshire
United Kingdom	City Hospitals Sunderland NHS	Sunderland
United Kingdom	Heart of England NHS Foundation Trust, Good Hope Hospital	Sutton Coldfield	Staffordshire
United States	Retina Institute of California	Arcadia	California
United States	Win Retina	Arcadia	California
United States	Western Carolina Retinal Associates, PA	Asheville	North Carolina
United States	Retina & Vitreous Center SO, PC	Ashland	Oregon
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Retina Associates	Austin	Texas
United States	The Retina Care Center	Baltimore	Maryland
United States	Retina Associates of Cleveland, Inc	Beachwood	Ohio
United States	Retina and Vitreous of Texas	Beaumont	Texas
United States	Vitreoretinal Associates of Washington	Bellevue	Washington
United States	Eye Foundation Hospital	Birmingham	Alabama
United States	Retina Center of New Jersey, LLC	Bloomfield	New Jersey
United States	The Eye Associates	Bradenton	Florida
United States	Pennsylvania Retina Specialists, P.C.	Camp Hill	Pennsylvania
United States	Retinal Diagnostic Center	Campbell	California
United States	Charlotte Eye Ear Nose & Throat Associates, PA	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Ohio State University	Columbus	Ohio
United States	DuPage Medical Group	Downers Grove	Illinois
United States	Midwest Retina, Inc.	Dublin	Ohio
United States	Kovach Eye Institute	Elmhurst	Illinois
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	The University of Texas Medical Branch	Galveston	Texas
United States	Retinal Consultants of Arizona	Gilbert	Arizona
United States	Specialty Eye Care Medical Center, Inc.	Glendale	California
United States	Retina Specialists of Michigan	Grand Rapids	Michigan
United States	Cumberland Valley Retina Consultants, P.C.	Hagerstown	Maryland
United States	Long Island Vitreoretinal Consultants	Hauppauge	New York
United States	University of California at Irvine Gavin Herbert Eye Institute	Irvine	California
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Retina Associates of Orange County	Laguna Hills	California
United States	Delaware Valley Retina Associates	Lawrenceville	New Jersey
United States	Sabates Eye Centers	Leawood	Kansas
United States	South Coast Retina Center	Long Beach	California
United States	MedEye Associates	Miami	Florida
United States	Retina Macula Specialists of Miami	Miami	Florida
United States	Premiere Retina Specialists	Midland	Texas
United States	West Virginia University Eye Institute	Morgantown	West Virginia
United States	Maculacare - New York	New York	New York
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	University Retina and Macula Associates	Oak Forest	Illinois
United States	East Bay Retina Consultants, Inc.	Oakland	California
United States	San Diego Retina Associates	Oceanside	California
United States	Paducah Retinal Center	Paducah	Kentucky
United States	Southern California Desert Retina Consultants	Palm Desert	California
United States	California Eye Specialist Medical Group	Pasadena	California
United States	Barnet Dulaney Perkins Eye Center - Phoenix	Phoenix	Arizona
United States	Fort Lauderdale Eye Institute	Plantation	Florida
United States	Oregon Health Sciences University	Portland	Oregon
United States	Retina Consultants, San Diego	Poway	California
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Retina Consultants of Southern California	Redlands	California
United States	Kaiser Permanente Riverside Medical Center	Riverside	California
United States	Retinal Consultants Medical Group, Inc.	Sacramento	California
United States	UC Davis Medical Center, Department of Ophthalmology	Sacramento	California
United States	University of Utah, John Moran Eye Center	Salt Lake City	Utah
United States	Retina Associates of South Texas, PA	San Antonio	Texas
United States	Pacific Eye Associates	San Francisco	California
United States	West Coast Retina Medical Group	San Francisco	California
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Northwest Arkansas Retina Associates	Springdale	Arkansas
United States	East Florida Eye Institute	Stuart	Florida
United States	Retina Vitreous Surgeons of Central NY, PC	Syracuse	New York
United States	Retina Associate of Florida, P.A.	Tampa	Florida
United States	Retina Vitreous Associates of Florida	Tampa	Florida
United States	Retina Centers, PC	Tucson	Arizona
United States	Wagner Macula and Retina Center	Virginia Beach	Virginia
United States	Wheaton Eye Clinic, Clinical Research Center, LLC	Wheaton	Illinois
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas
United States	Center for Retina and Macular Disease	Winter Haven	Florida
United States	Vitreo-Retinal Associates, Pc	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Denmark,  Hungary,  Italy,  Japan,  Netherlands,  Peru,  Poland,  Russian Federation,  South Africa,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Stable Vision at Week 52	Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.	Baseline to Week 52
Secondary	Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52	BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Mixed-effect model for repeated measures (MMRM) analysis was used. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.	Baseline to Week 52
Secondary	Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52	CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye. MMRM analysis was used.	Baseline to Week 52
Secondary	Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at Week 52	BCVA is measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA gain of more than 15 letters are noted. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.	Baseline to Week 52
Secondary	Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Week 52	NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision. Overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye: eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.	Baseline to Week 52