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Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Patients With Neovascular AMD

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT02859766
Collaborator
(none)
30
Enrollment
18
Locations
2
Arms
10.4
Actual Duration (Months)
1.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety and characterize the systemic pharmacokinetics (PK) of free and vascular endothelial growth factor (VEGF)-bound abicipar following single and multiple intravitreal injections of abicipar pegol in treatment-naïve patients with neovascular age-related macular degeneration (AMD).

Condition or Disease Intervention/Treatment Phase
  • Drug: Abicipar pegol
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Safety and Systemic Pharmacokinetics After Single and Repeat Doses of Abicipar Pegol (AGN-150998) Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration
Actual Study Start Date :
Dec 7, 2016
Actual Primary Completion Date :
Oct 20, 2017
Actual Study Completion Date :
Oct 20, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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]

Drug: Abicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection.
Other Names:
  • AGN-150998

    		•
    Experimental: Abicipar Pegol_Single Dose

    Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.

    Drug: Abicipar pegol
    Abicipar pegol 2 mg administered to the study eye by intravitreal injection.
    Other Names:
  • AGN-150998

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar [Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12]

    2. Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar [Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12]

    3. Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar [Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12]

    4. Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar [Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12]

    5. Area Under the Serum Concentration-Time Curve from Zero to the End of the Dosing Interval "tau" (AUC0-tau) for Free and VEGF-Bound Abicipar [Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12]

    6. Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar [Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12]

    Secondary Outcome Measures

    1. Serum Levels of Anti-abicipar Antibodies [Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12]

    2. Percentage of Participants with Treatment Emergent Adverse Events [Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12]

    3. Best Corrected Visual Acuity using an Eye Chart [Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12]

    4. Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam] [Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12]

    5. Changes from Baseline in General Physical Condition as Measured through General Physical Exam [Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12]

    6. Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate) [Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12]

    7. Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) [Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    -Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

    Exclusion Criteria:

    • History of or active periocular, ocular, or intraocular infection.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retinal Consultants of Arizona Gilbert Arizona United States 85296
    2 Win Retina Arcadia California United States 91006
    3 Retina Vitreous Associates Medical Group Beverly Hills California United States 90211
    4 Atlantis Retina Institute (Atlantis Eyecare) Huntington Beach California United States 92647
    5 Jacobs Retina Center, Shiley Eye Institute, UCSD La Jolla California United States 92093
    6 California Eye Specialists Medical Group, Inc-Private Clinic Pasadena California United States 91107
    7 University of Miami Coral Gables Florida United States 33146
    8 The Eye Institute of West Florida Largo Florida United States 33770
    9 Retina Specialty Institute Pensacola Florida United States 32503
    10 East Florida Eye Insititute Stuart Florida United States 34994
    11 Center for Retina and Macular Disease Winter Haven Florida United States 33880
    12 Raj K. Maturi, MD Indianapolis Indiana United States 46290
    13 Massachusetts Eye & Ear Boston Massachusetts United States 02114
    14 Eyesight Ophthalmic Services, PA Portsmouth New Hampshire United States 03801
    15 Caroline Eye Associates Southern Pines North Carolina United States 28387
    16 Cole Eye Institute, Cleveland Clinic Cleveland Ohio United States 44122
    17 Rocky Mountain Retina Consultants Salt Lake City Utah United States 84107
    18 Davis Duehr Dean Madison Wisconsin United States 53715

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Cathy Sutherland, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT02859766
    Other Study ID Numbers:
    • 150998-012
    First Posted:
    Aug 9, 2016
    Last Update Posted:
    Feb 8, 2018
    Last Verified:
    Feb 1, 2018
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Feb 8, 2018