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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

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).

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Abicipar pegol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
Actual Study Start Date : May 25, 2018
Actual Primary Completion Date : February 27, 2019
Actual Study Completion Date : February 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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 ]
  2. Changes From Baseline in General Physical Condition as Measured Through General Physical Exam [ Time Frame: Baseline to Week 28 ]
  3. Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG) [ Time Frame: Baseline to Week 28 ]
  4. Percentage of Participants With Change From Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) [ Time Frame: Baseline to Week 28 ]
  5. Percentage of Participants With Anti-abicipar Antibodies Measured in Serum [ Time Frame: Baseline to Week 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539549


Locations
Show Show 37 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joanne Li, MD Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] October 16, 2018
Statistical Analysis Plan  [PDF] July 25, 2018

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03539549    
Other Study ID Numbers: 1771-201-008
First Posted: May 29, 2018    Key Record Dates
Results First Posted: August 3, 2020
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases