Clinical trial NCT03539549: A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)
Official title: Evaluation of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-05-29
Enrollment: 124
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* Male or female participants, 50 years of age or older at the time of informed consent
* Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment) visits in the study eye
* BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to treatment) in the non-study eye

Exclusion Criteria:

* Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye)
* Previous or concurrent macular laser treatment (study eye)
* Cataract or refractive surgery within 3 months prior to baseline (study eye)

Primary outcomes:
measure: Percentage of Participants With Stable Vision
timeFrame: Baseline (Day 1) to Week 28
Secondary outcomes:
measure: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
timeFrame: Baseline (Day 1) to Week 28
measure: Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye
timeFrame: Baseline (Day 1) to Week 28
measure: Change Form Baseline in BCVA in the Study Eye
timeFrame: Baseline (Day 1) to Week 28
measure: Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye
timeFrame: Baseline (Day 1), Week 28
Other outcomes:
measure: Percentage of Participants With Change From Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam]
timeFrame: Baseline to Week 28
measure: Changes From Baseline in General Physical Condition as Measured Through General Physical Exam
timeFrame: Baseline to Week 28
measure: Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)
timeFrame: Baseline to Week 28
measure: Percentage of Participants With Change From Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)
timeFrame: Baseline to Week 28
measure: Percentage of Participants With Anti-abicipar Antibodies Measured in Serum
timeFrame: Baseline to Week 28
Locations:
city: Phoenix
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Tucson
country: United States
facility: Retina Associates Southwest, PC
state: Arizona
city: Arcadia
country: United States
facility: Win Retina
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Glendora
country: United States
facility: Mark B. Kislinger, MD, Inc.
state: California
city: Huntington Beach
country: United States
facility: Atlantis Retina Institute (Atlantis Eyecare)
state: California
city: Mountain View
country: United States
facility: N. California Retina Vitreous Associates Medical Group, INC.
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group, Inc
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Marietta
country: United States
facility: Georgia Retina, P.C.
state: Georgia
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Bloomington
country: United States
facility: Gailey Eye Clinic
state: Illinois
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD, PC
state: Indiana
city: Leawood
country: United States
facility: Sabates Eye Center
state: Kansas
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Albany
country: United States
facility: Capital Region Retina, PLLC
state: New York
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western New York
state: New York
city: Syracuse
country: United States
facility: Retina Vitreous Surgeons of Central NY, P.C.
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Camp Hill
country: United States
facility: Pennsylvania Retina Specialists, P.C.
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: Houston
country: United States
facility: Retinal Consultants of Houston
state: Texas
city: Midland
country: United States
facility: Premiere Retina Specialists
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Richmond
country: United States
facility: Retina Institute of Virginia
state: Virginia
Study officials:
affiliation: Allergan
name: Joanne Li, MD
role: STUDY_DIRECTOR
References: