Clinical trial NCT03362190: ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)
Official title: A Phase 2A Open-label Trial to Assess the Safety of ZIMURA™ (Anti-C5) Administered in Combination With LUCENTIS® 0.5 mg in Treatment Naive Subjects With Neovascular Age Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Zimura (previous name)
ARC1905
Lucentis
ranibizumab
Wet AMD
avacincaptad pegol
complement factor C5 inhibitor
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-12-05
Enrollment: 64
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: To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)


Eligibility criteria: Inclusion Criteria:

* Active subfoveal NVAMD

Exclusion Criteria:

* History or evidence of severe cardiac disease
* Any major surgical procedure within one month of trial entry
* Subjects with a clinically significant laboratory value
* Any treatment with an investigational agent in the past 60 days for any condition
* Women who are pregnant or nursing
* Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation
* Any prior treatment for AMD other than oral supplements of vitamins and minerals

Primary outcomes:
measure: Systemic Adverse Events
timeFrame: 6 months
measure: Ophthalmic Adverse Events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Change From Baseline - ECG
timeFrame: 6 months
measure: Mean Change From Baseline - Study Eye ETDRS Visual Acuity
timeFrame: 6 months
measure: Mean Change From Baseline - Vital Signs
timeFrame: 6 months
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute
state: Arizona
city: Tucson
country: United States
facility: Retina Centers PC
state: Arizona
city: Tucson
country: United States
facility: Retina Associates SW, PC
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Altamonte Springs
country: United States
facility: Florida Eye Clinic
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Peoria
country: United States
facility: Illinois Eye Center
state: Illinois
city: Wichita
country: United States
facility: Vitreo Retinal Consultants & Surgeons
state: Kansas
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Minneapolis
country: United States
facility: VitreoRetinal Surgery
state: Minnesota
city: Henderson
country: United States
facility: Retina Consultants of Nevada
state: Nevada
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Syracuse
country: United States
facility: Retina Vitreous Surgeons of CNY, PC
state: New York
city: Portland
country: United States
facility: Retina Northwest PC
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group
state: Texas
city: Budapest
country: Hungary
facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
city: Budapest
country: Hungary
facility: Budapest Retina Associates
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology
city: Riga
country: Latvia
facility: Dr. Solomatin's eye rehabilitation and vision correction centre
Study officials:
References: