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Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

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: NCT02462486
Recruitment Status : Completed
First Posted : June 4, 2015
Results First Posted : July 30, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Abicipar Pegol Drug: Ranibizumab Other: Sham Procedure Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 949 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (SEQUOIA Study)
Actual Study Start Date : June 25, 2015
Actual Primary Completion Date : April 12, 2018
Actual Study Completion Date : June 6, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Abicipar Pegol 2 mg (2Q8)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
 Drug: Abicipar Pegol
Abicipar pegol intravitreal injection.
Other Name: AGN-150998

Other: Sham Procedure
Sham injection.
Experimental: Abicipar Pegol 2 mg (2Q12)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
 Drug: Abicipar Pegol
Abicipar pegol intravitreal injection.
Other Name: AGN-150998

Other: Sham Procedure
Sham injection.
Active Comparator: Ranibizumab (rQ4)
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
 Drug: Ranibizumab
Ranibizumab intravitreal injection.
Other Name: Lucentis®


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Stable Vision at Week 52 [ Time Frame: Baseline to Week 52 ]
    Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is 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 percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.


Secondary Outcome Measures :
  1. Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52 [ Time Frame: Baseline to Week 52 ]
    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. Mixed-effect model for repeated measures (MMRM) analysis was used. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

  2. Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 [ Time Frame: Baseline to Week 52 ]
    CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye. MMRM analysis was used.

  3. Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at Week 52 [ Time Frame: Baseline to Week 52 ]
    BCVA is 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 percentage of participants with a BCVA gain of more than 15 letters are noted. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

  4. Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Week 52 [ Time Frame: Baseline to Week 52 ]
    NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision. Overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye: eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.


Eligibility Criteria
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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:

  • Diagnosis of age-related macular degeneration in at least 1 eye
  • Best corrected visual acuity of 20/40 to 20/320 in the study eye
  • Best corrected visual acuity of 20/200 or better in the non-study eye

Exclusion Criteria:

  • History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
  • Cataract or refractive surgery in the study eye within the last 3 months
Contacts and Locations
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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): NCT02462486


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joanne Li Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Statistical Analysis Plan  [PDF] May 16, 2018
Study Protocol  [PDF] April 10, 2018

More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02462486    
Other Study ID Numbers: 150998-006
2014-004580-20 ( EudraCT Number )
SEQUOIA ( Other Identifier: Allergan )
First Posted: June 4, 2015    Key Record Dates
Results First Posted: July 30, 2020
Last Update Posted: July 30, 2020
Last Verified: July 2020

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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
Ranibizumab
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents