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

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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Macular Degeneration
Intervention Drug: Abicipar pegol
Enrollment 124
Recruitment Details  
Pre-assignment Details A total of 124 participants were enrolled in the study. Out of 124, one participant was not treated with study drug and was subsequently discontinued from the study. The participant was not included in the Safety Population or analyses.
Arm/Group Title Abicipar Pegol 2 mg
Hide Arm/Group Description Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Period Title: Overall Study
Started 123
Completed 106
Not Completed 17
Reason Not Completed
Adverse Event             12
Lost to Follow-up             1
Death             2
Progressive Disease             1
Reason not Specified             1
Arm/Group Title Abicipar Pegol 2 mg
Hide Arm/Group Description Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Overall Number of Baseline Participants 123
Hide Baseline Analysis Population Description
Safety Population included all participants who received at least 1 administration of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants
78.3  (8.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants
Female
71
  57.7%
Male
52
  42.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants
Hispanic or Latino
4
   3.3%
Not Hispanic or Latino
119
  96.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
119
  96.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Best Corrected Visual Acuity (BCVA)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 122 participants
62.0  (12.19)
[1]
Measure Description: BCVA was measured using an eye chart and reported as number of letters read correctly using Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in study eye. Lower number of letters read correctly on eye chart, worse the vision (or visual acuity). Study eye: eye that meets entry criteria. If both eyes met entry criteria, eye with worse BCVA at baseline (Day 1) was selected as study eye. If both eyes had same BCVA values at baseline (Day 1), then participant had to select their non-dominant eye for treatment, or else right eye was selected.
[2]
Measure Analysis Population Description: Number analyzed is the number of participants with BCVA data available at baseline.
Central Retinal Thickness (CRT)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Microns
Number Analyzed 122 participants
353.1  (94.05)
[1]
Measure Description: 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. 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]
Measure Analysis Population Description: Number analyzed is the number of participants with CRT data available at Baseline.
1.Primary Outcome
Title Percentage of Participants With Stable Vision
Hide Description 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.
Time Frame Baseline (Day 1) to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least 1 administration of study treatment.
Arm/Group Title Abicipar Pegol 2 mg
Hide Arm/Group Description:
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Overall Number of Participants Analyzed 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.6
(94.2 to 99.8)
2.Secondary Outcome
Title Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Hide Description 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.
Time Frame Baseline (Day 1) to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least 1 administration of study treatment. Number analyzed is the number of participants with data available at the given time point.
Arm/Group Title Abicipar Pegol 2 mg
Hide Arm/Group Description:
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: microns
-82.5  (102.13)
3.Secondary Outcome
Title Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye
Hide Description 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.
Time Frame Baseline (Day 1) to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least 1 administration of study treatment. Overall number of participants analyzed are the participants with data available for analyses.
Arm/Group Title Abicipar Pegol 2 mg
Hide Arm/Group Description:
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of participants
0.9
4.Secondary Outcome
Title Change Form Baseline in BCVA in the Study Eye
Hide Description 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.
Time Frame Baseline (Day 1) to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least 1 administration of study treatment. Overall number of participants analyzed are the participants with data available for analyses.
Arm/Group Title Abicipar Pegol 2 mg
Hide Arm/Group Description:
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: letters
3.6  (7.19)
5.Secondary Outcome
Title Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye
Hide Description 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.
Time Frame Baseline (Day 1), Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least 1 administration of study treatment.
Arm/Group Title Abicipar Pegol 2 mg
Hide Arm/Group Description:
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Overall Number of Participants Analyzed 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.8
(5.2 to 16.6)
6.Other Pre-specified Outcome
Title Percentage of Participants With Change From Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam]
Hide Description [Not Specified]
Time Frame Baseline to Week 28
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Changes From Baseline in General Physical Condition as Measured Through General Physical Exam
Hide Description [Not Specified]
Time Frame Baseline to Week 28
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)
Hide Description [Not Specified]
Time Frame Baseline to Week 28
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Percentage of Participants With Change From Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)
Hide Description [Not Specified]
Time Frame Baseline to Week 28
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Percentage of Participants With Anti-abicipar Antibodies Measured in Serum
Hide Description [Not Specified]
Time Frame Baseline to Week 28
Outcome Measure Data Not Reported
Time Frame From first dose up to 28 weeks
Adverse Event Reporting Description Safety Population included all participants who received at least 1 administration of study treatment.
 
Arm/Group Title Abicipar Pegol 2 mg
Hide Arm/Group Description Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
All-Cause Mortality
Abicipar Pegol 2 mg
Affected / at Risk (%)
Total   2/123 (1.63%) 
Hide Serious Adverse Events
Abicipar Pegol 2 mg
Affected / at Risk (%)
Total   16/123 (13.01%) 
Cardiac disorders   
Atrial fibrillation  1  2/123 (1.63%) 
Tachyarrhythmia  1  1/123 (0.81%) 
Eye disorders   
Iritis  1  1/123 (0.81%) 
Retinal haemorrhage  1  1/123 (0.81%) 
Vitreous haemorrhage  1  1/123 (0.81%) 
Vitritis  1  1/123 (0.81%) 
Injury, poisoning and procedural complications   
Meniscus injury  1  1/123 (0.81%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/123 (0.81%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  2/123 (1.63%) 
B-cell lymphoma  1  1/123 (0.81%) 
Brain neoplasm  1  1/123 (0.81%) 
Glioblastoma  1  1/123 (0.81%) 
Oesophageal carcinoma  1  1/123 (0.81%) 
Nervous system disorders   
Cerebrovascular accident  1  1/123 (0.81%) 
Dysarthria  1  1/123 (0.81%) 
Vascular disorders   
Hypertension  1  1/123 (0.81%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abicipar Pegol 2 mg
Affected / at Risk (%)
Total   0/123 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan
Phone: 714-246-4500
EMail: IR-CTRegistration@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03539549    
Other Study ID Numbers: 1771-201-008
First Submitted: May 17, 2018
First Posted: May 29, 2018
Results First Submitted: July 17, 2020
Results First Posted: August 3, 2020
Last Update Posted: August 3, 2020