A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration (CEDAR)

• ClinicalTrials.gov Identifier: NCT02462928
• Recruitment Status: Completed
• First Posted: June 4, 2015
• Results First Posted: July 28, 2020
• Last Update Posted: July 28, 2020
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Tracking Information

• First Submitted Date: June 2, 2015
• First Posted Date: June 4, 2015
• Results First Submitted Date: July 16, 2020
• Results First Posted Date: July 28, 2020
• Last Update Posted Date: July 28, 2020
• Actual Study Start Date: June 25, 2015
• Actual Primary Completion Date: April 18, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 16, 2020)

Percentage of Participants With Stable Vision at Week 52 [ Time Frame: Baseline to Week 52 ]

Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and 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 loss of fewer than 15 letters are reported. 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.

• Original Primary Outcome Measures (submitted: June 2, 2015): Percentage of Patients with Best Corrected Visual Acuity (BCVA) Change from Baseline ≤15 Letters in the Study Eye [ Time Frame: Baseline, Week 52 ]

Current Secondary Outcome Measures (submitted: July 16, 2020)

• Mean Change From Baseline in BCVA in the Study Eye at Week 52 [ Time Frame: Baseline to Week 52 ]
  BCVA was measured using an eye chart and was 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 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 nondominant eye for treatment, or else the right eye was selected as the study eye. Mixed model for repeated measures (MMRM) analysis was used.
• 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 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. MMRM analysis was used.
• Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52 [ Time Frame: Baseline to Week 52 ]
  BCVA was measured using an eye chart and 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 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.
• Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye 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 related function. The overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding the general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye was defined as 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.

Original Secondary Outcome Measures (submitted: June 2, 2015)

• Change from Baseline in BCVA in the Study Eye [ Time Frame: Baseline, Week 52 ]
• Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye [ Time Frame: Baseline, Week 52 ]
• 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, Week 52 ]
• Change from Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score [ Time Frame: Baseline, Week 52 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
• Official Title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR Study)
• Brief Summary: This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Macular Degeneration

Intervention

• Drug: Abicipar Pegol
  Abicipar pegol intravitreal injection.
  Other Name: AGN-150998
• Drug: Ranibizumab
  Ranibizumab intravitreal injection.
  Other Name: Lucentis®
• Other: Sham Procedure
  Sham injection.

Study Arms

• Experimental: Abicipar Pegol 2 mg (2Q8)
  Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter 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.
  Interventions:

  • Drug: Abicipar Pegol
  • Other: Sham Procedure
• Experimental: Abicipar Pegol 2 mg (2Q12)
  Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter 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.
  Interventions:

  • Drug: Abicipar Pegol
  • Other: Sham Procedure
• Active Comparator: Ranibizumab 0.5 mg (rQ4)
  Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
  Intervention: Drug: Ranibizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 12, 2018): 939
• Original Estimated Enrollment (submitted: June 2, 2015): 900
• Actual Study Completion Date: June 19, 2019
• Actual Primary Completion Date: April 18, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Austria, Chile, Colombia, Czechia, France, Germany, Hong Kong, Israel, Korea, Republic of, Latvia, New Zealand, Philippines, Singapore, Spain, Switzerland, United States
• Removed Location Countries: Czech Republic, Portugal

Administrative Information

• NCT Number: NCT02462928
• Other Study ID Numbers: 150998-005; 2014-004579-22 ( EudraCT Number ); CEDAR ( Other Identifier: Allergan )
• Has Data Monitoring Committee: Yes

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: Not Provided
• Current Responsible Party: Allergan
• Original Responsible Party: Same as current
• Current Study Sponsor: Allergan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Joanne Li; Allergan

• PRS Account: Allergan
• Verification Date: July 2020