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A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539549
Recruitment Status : Completed
First Posted : May 29, 2018
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE May 17, 2018
First Posted Date  ICMJE May 29, 2018
Results First Submitted Date  ICMJE July 17, 2020
Results First Posted Date  ICMJE August 3, 2020
Last Update Posted Date August 3, 2020
Actual Study Start Date  ICMJE May 25, 2018
Actual Primary Completion Date February 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2020)
Percentage of Participants With Stable Vision [ Time Frame: Baseline (Day 1) to Week 28 ]
Stable vision was defined as a loss of fewer than 15 letters in Best Corrected Visual Acuity (BCVA) compared to baseline. BCVA was measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • Change from Baseline in Best Corrected Visual Acuity ( BCVA) in the study eye using Early-Treatment Diabetic Retinopathy study (ETDRS) Scale [ Time Frame: Baseline to week 28 ]
  • Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam] [ Time Frame: Baseline to Week 28 ]
  • Changes from Baseline in General Physical Condition as Measured through General Physical Exam [ Time Frame: Baseline to Week 28 ]
  • Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG) [ Time Frame: Baseline to Week 28 ]
  • Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) [ Time Frame: Baseline to Week 28 ]
  • Percentage of Participants with anti-abicipar antibiodies measured in serum [ Time Frame: Baseline to Week 28 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2020)
  • Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye [ Time Frame: Baseline (Day 1) to Week 28 ]
    CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
  • Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye [ Time Frame: Baseline (Day 1) to Week 28 ]
    BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
  • Change Form Baseline in BCVA in the Study Eye [ Time Frame: Baseline (Day 1) to Week 28 ]
    BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
  • Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye [ Time Frame: Baseline (Day 1), Week 28 ]
    BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye [ Time Frame: Baseline to week 24 ]
  • Percentage of Patients with Best Corrected Visual Acuity (BCVA) Change from Baseline ≤15 Letters in the Study Eye [ Time Frame: Baseline to Week 28 ]
  • Change from Baseline in BCVA in the Study Eye [ Time Frame: Baseline to Week 28 ]
  • Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale [ Time Frame: Baseline to Week 28 ]
  • Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye [ Time Frame: Baseline to Week 28 ]
Current Other Pre-specified Outcome Measures
 (submitted: July 17, 2020)
  • Percentage of Participants With Change From Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam] [ Time Frame: Baseline to Week 28 ]
  • Changes From Baseline in General Physical Condition as Measured Through General Physical Exam [ Time Frame: Baseline to Week 28 ]
  • Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG) [ Time Frame: Baseline to Week 28 ]
  • Percentage of Participants With Change From Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) [ Time Frame: Baseline to Week 28 ]
  • Percentage of Participants With Anti-abicipar Antibodies Measured in Serum [ Time Frame: Baseline to Week 28 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)
Official Title  ICMJE Evaluation of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Macular Degeneration
Intervention  ICMJE Drug: Abicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Study Arms  ICMJE Experimental: Abicipar pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Intervention: Drug: Abicipar pegol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2019)
124
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
100
Actual Study Completion Date  ICMJE February 27, 2019
Actual Primary Completion Date February 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03539549
Other Study ID Numbers  ICMJE 1771-201-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joanne Li, MD Allergan
PRS Account Allergan
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP