Clinical trial NCT03345082: A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD
Official title: A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Opthea Limited
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 366
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.


Eligibility criteria: Inclusion Criteria:

* Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to age-related macular AMD
* An ETDRS BCVA score between 60 and 25 (inclusive) letters

Exclusion Criteria:

* Previous treatment for wet AMD or previous treatment for CNV due to other causes in the Study Eye
* Clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
* Poorly controlled diabetes mellitus (defined as HbA1c\>7%)
* Any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for the study

Primary outcomes:
measure: Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Proportion of participants gaining 15 or more ETDRS BCVA letters
timeFrame: Baseline to Week 24
measure: Area under the ETDRS BCVA over time curve
timeFrame: Baseline to Week 24
measure: Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT)
timeFrame: Baseline to Week 24
measure: Change in intra-retinal fluid and sub-retinal fluid on SD-OCT
timeFrame: Baseline to Week 24
measure: Proportion of participants losing 15 or more letters (on ETDRS BCVA chart)
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Opthea Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Opthea Investigational Site
state: Arizona
city: Beverly Hills
country: United States
facility: Opthea Investigational Site
state: California
city: Encino
country: United States
facility: Opthea Investigational Site
state: California
city: Palm Desert
country: United States
facility: Opthea Investigational Site
state: California
city: Redlands
country: United States
facility: Opthea Investigational Site
state: California
city: Sacramento
country: United States
facility: Opthea Study Site
state: California
city: Sacramento
country: United States
facility: Opthea Investigational Site
state: California
city: San Diego
country: United States
facility: Opthea Investigational Site
state: California
city: Santa Ana
country: United States
facility: Opthea Investigational Site
state: California
city: Santa Barbara
country: United States
facility: Opthea Investigational Site
state: California
city: Santa Maria
country: United States
facility: Opthea Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Opthea Investigational Site
state: Colorado
city: Golden
country: United States
facility: Opthea Investigational Site
state: Colorado
city: Boynton Beach
country: United States
facility: Opthea Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Opthea Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Opthea Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Opthea Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Opthea Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Opthea Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Opthea Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: Opthea Investigational Site
state: Florida
city: Augusta
country: United States
facility: Opthea Investigational Site
state: Georgia
city: Shawnee Mission
country: United States
facility: Opthea Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Opthea Investigational Site
state: Kansas
city: Paducah
country: United States
facility: Opthea Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Opthea Investigational Site
state: Maryland
city: Grand Rapids
country: United States
facility: Opthea Investigational Site
state: Michigan
city: Las Vegas
country: United States
facility: Opthea Investigational Site
state: Nevada
city: Reno
country: United States
facility: Opthea Investigational Site
state: Nevada
city: Edison
country: United States
facility: Opthea Investigational Site
state: New Jersey
city: Teaneck
country: United States
facility: Opthea Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Opthea Investigational Site
state: New Mexico
city: Lynbrook
country: United States
facility: Opthea Investigational Site
state: New York
city: Rochester
country: United States
facility: Opthea Investigational Site
state: New York
city: Syracuse
country: United States
facility: Opthea Investigational Site
state: New York
city: Asheville
country: United States
facility: Opthea Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Opthea Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Opthea Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Opthea Investigational Site
state: Ohio
city: Portland
country: United States
facility: Opthea Investigational Site
state: Oregon
city: Camp Hill
country: United States
facility: Opthea Investigational Site
state: Pennsylvania
city: Kingston
country: United States
facility: Opthea Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Opthea Investigational Site
state: Pennsylvania
city: Ladson
country: United States
facility: Opthea Investigational Site
state: South Carolina
city: West Columbia
country: United States
facility: Opthea Investigational Site
state: South Carolina
city: Abilene
country: United States
facility: Opthea Investigational Site
state: Texas
city: Austin
country: United States
facility: Opthea Investigational Site
state: Texas
city: Houston
country: United States
facility: Opthea Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Opthea Investigational Site
state: Texas
city: The Woodlands
country: United States
facility: Opthea Investigational Site
state: Texas
city: Willow Park
country: United States
facility: Opthea Investigational Site
state: Texas
city: Fairfax
country: United States
facility: Opthea Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Opthea Investigational Site
state: Virginia
city: Silverdale
country: United States
facility: Opthea Investigational Site
state: Washington
city: Hradec Králové
country: Czechia
facility: Opthea Investigational Site
city: Praha 10
country: Czechia
facility: Opthea Investigational Site
city: Praha
country: Czechia
facility: Opthea Investigational Site
city: Créteil
country: France
facility: Opthea Investigational Site
city: Dijon
country: France
facility: Opthea Investigational Site
city: Paris
country: France
facility: Opthea Investigational Site
city: Paris
country: France
facility: Opthea Investigational Site
city: Strasbourg
country: France
facility: Opthea Investigational Site
city: Écully
country: France
facility: Opthea Investigational Site
city: Budapest
country: Hungary
facility: Opthea Investigational Site
city: Budapest
country: Hungary
facility: Opthea Investigational Site
city: Budapest
country: Hungary
facility: Opthea Investigational Site
city: Nyíregyháza
country: Hungary
facility: Opthea Investigational Site
city: Szeged
country: Hungary
facility: Opthea Investigational Site
city: Haifa
country: Israel
facility: Opthea Investigational Site
city: Haifa
country: Israel
facility: Opthea Investigational Site
city: Jerusalem
country: Israel
facility: Opthea Investigational Site
city: Jerusalem
country: Israel
facility: Opthea Investigational Site
city: Kfar Saba
country: Israel
facility: Opthea Investigational Site
city: Petach Tikva
country: Israel
facility: Opthea Investigational Site
city: Reẖovot
country: Israel
facility: Opthea Investigational Site
city: Tel Aviv
country: Israel
facility: Opthea Investigational Site
city: Bologna
country: Italy
facility: Opthea Investigational Site
city: Florence
country: Italy
facility: Opthea Investigational Site
city: Milan
country: Italy
facility: Opthea Investigational Site
city: Milan
country: Italy
facility: Opthea Investigational Site
city: Roma
country: Italy
facility: Opthea Investigational Site
city: Jelgava
country: Latvia
facility: Opthea Investigational Site
city: Riga
country: Latvia
facility: Opthea Investigational Site
city: Riga
country: Latvia
facility: Opthea Investigational Site
city: Riga
country: Latvia
facility: Opthea Investigational Site
city: Bydgoszcz
country: Poland
facility: Opthea Investigational Site
city: Gdańsk
country: Poland
facility: Opthea Investigational Site
city: Katowice
country: Poland
facility: Opthea Investigational Site
city: Kraków
country: Poland
facility: Opthea Investigational Site
city: Lublin
country: Poland
facility: Opthea Investigationa Site
city: Lublin
country: Poland
facility: Opthea Investigational Site
city: Wrocław
country: Poland
facility: Opthea Investigational Site
city: Barcelona
country: Spain
facility: Opthea Investigational Site
city: Bilbao
country: Spain
facility: Opthea Investigational Site
city: Madrid
country: Spain
facility: Opthea Investigational Site
city: Oviedo
country: Spain
facility: Opthea Investigational Site
city: Pamplona
country: Spain
facility: Opthea Investigational Site
city: Santiago De Compostela
country: Spain
facility: Opthea Investigational Site
city: Valencia
country: Spain
facility: Opthea Investigational Site
city: Valladolid
country: Spain
facility: Opthea Investigational Site
city: Bristol
country: United Kingdom
facility: Opthea Investigational Site
city: Frimley
country: United Kingdom
facility: Opthea Investigational Site
city: Glasgow
country: United Kingdom
facility: Opthea Investigational Site
city: London
country: United Kingdom
facility: Opthea Investigational Site
city: Maidstone
country: United Kingdom
facility: Opthea Investigational Site
city: Sheffield
country: United Kingdom
facility: Opthea Investigational Site
city: Wolverhampton
country: United Kingdom
facility: Opthea Investigational Site
Study officials:
affiliation: Opthea Limited
name: Study Director
role: STUDY_DIRECTOR
References: