Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Patients With Neovascular AMD
NCT ID: NCT02859766
Last Updated: 2018-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2016-12-07
2017-10-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)
NCT03539549
Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Japanese Patients With Neovascular AMD
NCT03335852
A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
NCT02181517
A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
NCT02462928
Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD
NCT02461771
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Abicipar Pegol_Repeat Dose
Treatment Group 1: Abicipar pegol 2 mg administered to the study eye by intravitreal injection, 3 injections 4 weeks apart. \[Day 1, Weeks 4 and 8\]
Abicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection.
Abicipar Pegol_Single Dose
Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.
Abicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Previous use of verteporfin photodynamic therapy (PDT) or any ocular anti-angiogenic therapy (eg, aflibercept, bevacizumab, ranibizumab, pegaptanib), approved or investigational, for the treatment of neovascular AMD or previous therapeutic radiation in the region.
* Prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD.
* Macular hemorrhage that involves the center of fovea in the study eye.
* Any prior or current systemic or ocular treatment (including surgery) for neovascular AMD in the study eye.
* Treatment with ocular corticosteroid injections or implants within 6 months in the study eye.
* History or evidence of eye surgery: Pars plana vitrectomy, Submacular surgery or other surgical interventions for AMD, Incisional glaucoma surgery or Cataract or refractive surgery within the last 3 months.
* AMD in the non-study eye that requires anti-VEGF treatment.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cathy Sutherland
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Retinal Consultants of Arizona
Gilbert, Arizona, United States
Win Retina
Arcadia, California, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Atlantis Retina Institute (Atlantis Eyecare)
Huntington Beach, California, United States
Jacobs Retina Center, Shiley Eye Institute, UCSD
La Jolla, California, United States
California Eye Specialists Medical Group, Inc-Private Clinic
Pasadena, California, United States
University of Miami
Coral Gables, Florida, United States
The Eye Institute of West Florida
Largo, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
East Florida Eye Insititute
Stuart, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Raj K. Maturi, MD
Indianapolis, Indiana, United States
Massachusetts Eye & Ear
Boston, Massachusetts, United States
Eyesight Ophthalmic Services, PA
Portsmouth, New Hampshire, United States
Caroline Eye Associates
Southern Pines, North Carolina, United States
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, United States
Davis Duehr Dean
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
150998-012
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.