Clinical trial NCT02686658: Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Official title: A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Geographic Atrophy
Dry Age-Related Macular Degeneration
Keywords: Geographic Atrophy (GA)
Dry age-related macular degeneration
AMD
Zimura (previous name)
Anti-inflammatory
complement factor C5 inhibitor
ARC1905
avacincaptad pegol
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-02-19
Enrollment: 286
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: The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Detailed description: Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.

Eligibility criteria: Inclusion Criteria:

* Participants of either gender aged ≥ 50 years
* Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria:

* Evidence of Choroidal Neovascularization (CNV)
* GA secondary to any condition other than AMD
* Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
* Any intraocular surgery or thermal laser within three (3) months of trial entry
* Any prior thermal laser in the macular region, regardless of indication
* Any ocular or periocular infection in the twelve (12) weeks
* Previous therapeutic radiation in the region of the study eye
* Any sign of diabetic retinopathy in either eye

Primary outcomes:
measure: Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters
timeFrame: Baseline and 12 months
measure: Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Campbell
country: United States
state: California
city: Fresno
country: United States
state: California
city: Fullerton
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Redlands
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Altamonte Springs
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Stuart
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: West Des Moines
country: United States
state: Iowa
city: Shawnee Mission
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Chevy Chase
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Henderson
country: United States
state: Nevada
city: Reno
country: United States
state: Nevada
city: Rochester
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: West Mifflin
country: United States
state: Pennsylvania
city: Ladson
country: United States
state: South Carolina
city: West Columbia
country: United States
state: South Carolina
city: Abilene
country: United States
state: Texas
city: Amarillo
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Grapevine
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Willow Park
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Osijek
country: Croatia
facility: Clinical hospital center Osijek
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno
city: Hradec Králové
country: Czechia
facility: Faculty Hospital Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha
country: Czechia
facility: Axon Clinical SRO
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: Dr.Kai Noor Eye Clinic
city: Budapest
country: Hungary
facility: Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Veszprém
country: Hungary
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
Study officials:
References:
citation: Jaffe GJ, Westby K, Csaky KG, Mones J, Pearlman JA, Patel SS, Joondeph BC, Randolph J, Masonson H, Rezaei KA. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021 Apr;128(4):576-586. doi: 10.1016/j.ophtha.2020.08.027. Epub 2020 Sep 1.