Клинические исследование Neovascular Age-related Macular Degeneration: 2.0 mg OPT-302, 0.5 mg ranibizumab, Sham

Спонсоры	Ведущий спонсор: Opthea Limited
Источник	Opthea Limited
Краткое содержание	A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Общий статус

Recruiting

Дата начала

2021-03-12

Дата завершения

2024-12-01

Дата первичного завершения

2023-12-01

Фаза

Phase 3

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters	Baseline to Week 52

Вторичный результат

Мера	Временное ограничение
Proportion of participants gaining 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters	Baseline to Week 52
Proportion of participants gaining 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters	Baseline to Week 52
Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by SD-OCT	at Week 52
Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA)	Baseline to Week 52
Change in central sub-field thickness (CST) by spectral domain optical coherence tomography (SD-OCT)	Baseline to Week 52
Change in National Eye Institute 25-question visual function questionnaire (NEI VFQ-25) composite score	Baseline to Week 52

Регистрация

990

Состояние	Neovascular Age-related Macular Degeneration
Вмешательство	Тип вмешательства: Biological Название вмешательства: 2.0 mg OPT-302 Описание: intravitreal injection Тип вмешательства: Biological Название вмешательства: 0.5 mg ranibizumab Описание: intravitreal injection Тип вмешательства: Procedure Название вмешательства: Sham Описание: intravitreal injection Этикетка Arm Group: 0.5 mg ranibizumab with sham
Приемлемость	Критерии: Inclusion Criteria: - Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye. - An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye. Main Exclusion Criteria: - Any previous treatment for neovascular AMD. - Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging. - Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study. Пол: All Минимальный возраст: 50 Years Максимальный возраст: N/A Здоровые волонтеры: No

Состояние

Neovascular Age-related Macular Degeneration

Вмешательство

Тип вмешательства: Biological

Название вмешательства: 2.0 mg OPT-302

Описание: intravitreal injection

Тип вмешательства: Biological

Название вмешательства: 0.5 mg ranibizumab

Описание: intravitreal injection

Тип вмешательства: Procedure

Название вмешательства: Sham

Описание: intravitreal injection

Этикетка Arm Group: 0.5 mg ranibizumab with sham

Приемлемость

Критерии:

Inclusion Criteria: - Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye. - An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye. Main Exclusion Criteria: - Any previous treatment for neovascular AMD. - Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging. - Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.

Пол:

All

Минимальный возраст:

50 Years

Максимальный возраст:

N/A

Здоровые волонтеры:

Общий контакт

Фамилия: Opthea Limited

Телефон: +61 3 9826 0399

Расположение

Объект:	Положение дел:	Контакт:
ShORe Investigational Site \| Phoenix, Arizona, 85020, United States	Recruiting	Study Manager
ShORe Investigational Site \| Tucson, Arizona, 85704, United States	Recruiting	Study Manager
ShORe Investigational Site \| Bakersfield, California, 93309, United States	Recruiting	Study Manager
ShORe Investigational Site \| Campbell, California, 95008, United States	Recruiting	Study Manager
ShORe Investigational Site \| Encino, California, 91436, United States	Recruiting	Study Manager
ShORe Investigational Site \| Fullerton, California, 92835, United States	Recruiting	Study Manager
ShORe Investigational Site \| Glendale, California, 91203, United States	Recruiting	Study Manager
ShORe Investigational Site \| Laguna Hills, California, 92653, United States	Recruiting	Study Manager
ShORe Investigational Site \| Long Beach, California, 90807, United States	Recruiting	Study Manager
ShORe Investigational Site \| Mountain View, California, 94040, United States	Recruiting	Study Manager
ShORe Investigational site \| Pasadena, California, 91107, United States	Recruiting	Study Manager
ShORe Investiagtional Site \| Poway, California, 92064, United States	Recruiting	Study Manager
ShORe Investigational Site \| Sacramento, California, 95825, United States	Recruiting	Study Manager
ShORe Investigational Site \| Santa Ana, California, 92705, United States	Recruiting	Study Manager
ShORe Investigational Site \| Colorado Springs, Colorado, 80909, United States	Recruiting	Study Manager
ShORe Investigational Site \| Denver, Colorado, 80206, United States	Recruiting	Study Manager
ShORe Investigational Site \| Longmont, Colorado, 80503, United States	Recruiting	Study Manager
ShORe Investigational Site \| Fort Lauderdale, Florida, 33309, United States	Recruiting	Study Manager
ShORe Investigational Site \| Gainesville, Florida, 32607, United States	Recruiting	Study Manager
ShORe Investigational Site \| Lakeland, Florida, 338805, United States	Recruiting	Study Manager
ShORe Investigational Site \| Miami, Florida, 33126, United States	Recruiting	Study Manager
ShORe Investigational Site \| Pensacola, Florida, 32503, United States	Recruiting	Study Manager
ShORe Investigational Site \| Pinellas Park, Florida, 33782, United States	Recruiting	Study Manager
ShORe Investigational Site \| Sandy Springs, Georgia, 30328, United States	Recruiting	Study Manager
ShORe Investigational Site \| Lemont, Illinois, 60439, United States	Recruiting	Study Manager
ShORe Investigational Site \| Indianapolis, Indiana, 46290, United States	Recruiting
ShORe Investigational Site \| Baltimore, Maryland, 21209, United States	Recruiting	Study Manager
ShORe Investigational Site \| Baltimore, Maryland, 21237, United States	Recruiting	Study Manager
ShORe Investigational Site \| Hagerstown, Maryland, 21740, United States	Recruiting	Study Manager
ShORe Investigational Site \| Towson, Maryland, 21204, United States	Recruiting	Study Manager
ShORe Investigational Site \| Springfield, Massachusetts, 01107, United States	Recruiting	Study Manager
ShORe Investigational Site \| Columbia, Missouri, 65212, United States	Recruiting	Study Manager
ShORe Investigational Site \| Florissant, Missouri, 63031, United States	Recruiting	Study Manager
ShORe Investigational Site \| Reno, Nevada, 89502, United States	Recruiting	Study Manager
ShORe Investigational Site \| Toms River, New Jersey, 08755, United States	Recruiting	Study Manager
ShORe Investigational Site \| Liverpool, New York, 13088, United States	Recruiting	Study Manager
ShORe Investigational Site \| Edmond, Oklahoma, 73013, United States	Recruiting	Study Manager
ShORe Investigational Site \| Tulsa, Oklahoma, 74114, United States	Recruiting	Study Manager
ShORe Investigational Site \| Eugene, Oregon, 97401, United States	Recruiting	Study Manager
ShORe Investigational Site \| Portland, Oregon, 97239, United States	Recruiting	Study Manager
ShORe Investigational Site \| Salem, Oregon, 97302, United States	Recruiting	Study Manager
ShORe Investigational Site \| Erie, Pennsylvania, 16507, United States	Recruiting	Study Manager
ShORe Investigational Site \| Beaufort, South Carolina, 29902, United States	Recruiting	Study Manager
ShORe Investigational Site \| Ladson, South Carolina, 29456, United States	Recruiting	Study Manager
ShORe Investigational Site \| Arlington, Texas, 76012, United States	Recruiting	Study Manager
ShORe Investigational Site \| Austin, Texas, 78731, United States	Recruiting	Study Manager
ShORe Investigational Site \| Dallas, Texas, 75231, United States	Recruiting	Study Manager
ShORe Investigational Site \| Houston, Texas, 77030, United States	Recruiting	Study Manager
ShORe Investigational Site \| McAllen, Texas, 78503, United States	Recruiting	Study Manager
ShORe Investigational Site \| San Antonio, Texas, 78240, United States	Recruiting	Study Manager
ShORe Investigational Site \| Tyler, Texas, 75701, United States	Recruiting	Study Manager
ShORe Investigational Site \| Willow Park, Texas, 76087, United States	Recruiting	Study Manager
ShORe Investigational Site \| Lynchburg, Virginia, 24502, United States	Recruiting	Study Manager
ShORe Investigational Site \| Capital federal, Ciudad Autonoma Buenos Aires, C1120AAN, Argentina	Recruiting	Study Manager
ShORe Investigational Site \| Rosario, Santa Fe, S2000ANJ, Argentina	Recruiting	Study Manager
ShORe Investigational Site \| Rosario, Sante Fe, S2000DLA, Argentina	Recruiting	Study Manager
ShORe Investigational Site \| Ciudad Autonoma de Buenos Aire, C1015ABO, Argentina	Recruiting	Study Manager
ShORe Investigational Site \| Hurstville, New South Wales, 2220, Australia	Recruiting	Study Manager
ShORe Investigational Site \| Melbourne, Victoria, 3050, Australia	Recruiting	Study Manager
ShORe Investigational Site \| Brasília, Brazil	Not yet recruiting	Study Manager
ShORe Investigational Site \| Sofia, Bulgaria	Not yet recruiting	Study Manager
ShORe Investigational Site \| Calgary, Alberta, T2A 0Z9, Canada	Recruiting	Study Manager
ShORe Investigational Site \| Mississauga, Ontario, L4W1W9, Canada	Recruiting	Study Manager
ShORe Investigational Site \| Pardubice, 53002, Czechia	Recruiting	Study Manager
ShORe Investigational Site \| Praha, 10034, Czechia	Recruiting	Study Manager
ShORe Investigational Site \| Copenhagen, Denmark	Not yet recruiting	Study Manager
ShORe Investigational Site \| Nice, Alpes-Maritimes, 6000, France	Recruiting	Study Manager
ShORe Investigational Site \| Strasbourg, Bas Rhin, 6700, France	Recruiting	Study Manager
ShORe Investigational Site \| Créteil, Val De Marr, 94010, France	Recruiting	Study Manager
ShORe Investigational Site \| Münster, Nordrhein, 48145, Germany	Recruiting	Study Manager
ShORe Investigational Site \| Athens, Greece	Not yet recruiting	Study Manager
ShORe Investigational Site \| Budapest, 1133, Hungary	Recruiting	Study Manager
ShORe Investigational Site \| Szombathely, 9700, Hungary	Recruiting	Study Manager
ShORe Investigational Site \| New Delhi, India	Not yet recruiting	Study Manager
ShORe Investigational Site \| Petach Tikva, 4941492, Israel	Recruiting	Study Manager
ShORe Investigational Site \| Roma, 168, Italy	Recruiting	Study Manager
ShORe Investigational Site \| Siena, 52100, Italy	Recruiting	Study Manager
ShORe Investigational Site \| Seongnam, Gyeonggi-do, 1360, Korea, Republic of	Recruiting	Study Manager
ShORe Investigational Site \| Daegu, Gyeongsangbuk-do, 42415, Korea, Republic of	Recruiting	Study Manager
ShORe Investigational Site \| Busan, 48108, Korea, Republic of	Recruiting	Study Manager
ShORe Investigational Site \| Gwangju, 61469, Korea, Republic of	Recruiting	Study Manager
ShORe Investigational Site \| Seoul, 3080, Korea, Republic of	Recruiting	Study Manager
ShORe Investigational Site \| Seoul, 7301, Korea, Republic of	Recruiting	Study Manager
ShORe Investigational Site \| Riga, LV-1002, Latvia	Recruiting	Study Manager
ShORe Investigational Site \| Kuala Lumpur, Malaysia	Not yet recruiting	Study Manager
ShORe Investigational Site \| Olsztyn, 10-424, Poland	Recruiting	Study Manager
ShORe Investigational Site \| Tarnowskie Góry, 42-600, Poland	Recruiting	Study Manager
ShORe Investigational Site \| Warsaw, 00631, Poland	Recruiting	Study Manager
ShORe Investigational Site \| Penza, 440026, Russian Federation	Recruiting	Study Manager
ShORe Investigational Site \| Sant Cugat Del Vallès, Barcelona, 8195, Spain	Recruiting	Study Manager
ShORe Investigational Site \| Burjassot, Valencia, 46100, Spain	Recruiting	Study Manager
ShORe Investigational Site \| Barcelona, 8021, Spain	Recruiting	Study Manager
ShORe Investigational Site \| Burgos, 9005, Spain	Recruiting	Study Manager
ShORe Investigational Site \| Córdoba, 14012, Spain	Recruiting	Study Manager
ShORe Investigational Site \| Valencia, 46015, Spain	Recruiting	Study Manager
ShORe Investigational Site \| Pathum Wan, Bangkok, 10330, Thailand	Recruiting	Study Manager
ShORe Investigational Site \| Kiev, Ukraine	Not yet recruiting	Study Manager
ShORe Investigational Site \| Leicester, Leicestershire, LE15 WW, United Kingdom	Recruiting	Study Manager
ShORe Investigational Site \| Bristol, Somerset, BS12LX, United Kingdom	Recruiting	Study Manager
ShORe Investigational Site \| Guildford, Surrey, GU27XX, United Kingdom	Recruiting	Study Manager
ShORe Investigational Site \| Wolverhampton, West Midlands, WV10 0QP, United Kingdom	Recruiting	Study Manager
ShORe Investigational Site \| London, SE59RS, United Kingdom	Recruiting	Study Manager

Расположение Страны	Argentina Australia Brazil Bulgaria Canada Czechia Denmark France Germany Greece Hungary India Israel Italy Korea, Republic of Latvia Malaysia Poland Russian Federation Spain Thailand Ukraine United Kingdom United States
Дата проверки	2022-01-01
Ответственная сторона	Тип: Sponsor
Имеет расширенный доступ	No
Состояние Просмотр	Macular Degeneration Wet Macular Degeneration
Количество рук	3
Группа вооружений	Метка: 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302 Тип: Experimental Описание: 0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals. Метка: 0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302 Тип: Experimental Описание: 0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not. Метка: 0.5 mg ranibizumab with sham Тип: Sham Comparator Описание: 0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.
Акроним	ShORe
Данные пациента	No
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)