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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03539549
• Collaborator: (none)
• Enrollment: 124
• Locations: 37
• Arm: 1
• Actual Duration (Months): 9.1
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Feb 27, 2019
• Actual Study Completion Date: Feb 27, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Stable Vision [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 [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 [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 [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 [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] [Baseline to Week 28]

2. Changes From Baseline in General Physical Condition as Measured Through General Physical Exam [Baseline to Week 28]

3. Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG) [Baseline to Week 28]

4. Percentage of Participants With Change From Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) [Baseline to Week 28]

5. Percentage of Participants With Anti-abicipar Antibodies Measured in Serum [Baseline to Week 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barnet Dulaney Perkins Eye Center	Phoenix	Arizona	United States	85016
2	Retina Associates Southwest, PC	Tucson	Arizona	United States	85710
3	Win Retina	Arcadia	California	United States	91006
4	Retina Consultants of Orange County	Fullerton	California	United States	92835
5	Mark B. Kislinger, MD, Inc.	Glendora	California	United States	91741
6	Atlantis Retina Institute (Atlantis Eyecare)	Huntington Beach	California	United States	92647
7	N. California Retina Vitreous Associates Medical Group, INC.	Mountain View	California	United States	94040
8	California Eye Specialists Medical Group, Inc	Pasadena	California	United States	91107
9	Retinal Consultants Medical Group, Inc.	Sacramento	California	United States	95819
10	Colorado Retina Associates	Golden	Colorado	United States	80401
11	Retina Specialty Institute	Pensacola	Florida	United States	32503
12	Retina Vitreous Associates of Florida	Saint Petersburg	Florida	United States	33711
13	Center for Retina and Macular Disease	Winter Haven	Florida	United States	33880
14	Georgia Retina, P.C.	Marietta	Georgia	United States	30060
15	Marietta Eye Clinic	Marietta	Georgia	United States	30060
16	Gailey Eye Clinic	Bloomington	Illinois	United States	61704
17	Raj K. Maturi, MD, PC	Indianapolis	Indiana	United States	46290
18	Sabates Eye Center	Leawood	Kansas	United States	66211
19	Sierra Eye Associates	Reno	Nevada	United States	89502
20	Capital Region Retina, PLLC	Albany	New York	United States	12206
21	Ophthalmic Consultants of Long Island	Lynbrook	New York	United States	11580
22	Retina Associates of Western New York	Rochester	New York	United States	14620
23	Retina Vitreous Surgeons of Central NY, P.C.	Syracuse	New York	United States	13224
24	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242
25	Pennsylvania Retina Specialists, P.C.	Camp Hill	Pennsylvania	United States	17011
26	Charleston Neuroscience Institute	Ladson	South Carolina	United States	29456
27	Black Hills Regional Eye Institute	Rapid City	South Dakota	United States	57701
28	Retina Research Institute of Texas	Abilene	Texas	United States	79606
29	Texas Retina Associates	Arlington	Texas	United States	76012
30	Austin Retina Associates	Austin	Texas	United States	78705
31	Texan Eye	Austin	Texas	United States	78731
32	Retinal Consultants of Houston	Houston	Texas	United States	77030
33	Premiere Retina Specialists	Midland	Texas	United States	79706
34	Retinal Consultants of San Antonio	San Antonio	Texas	United States	78240
35	Retina Consultants of Houston	The Woodlands	Texas	United States	77384
36	Strategic Clinical Research Group, LLC	Willow Park	Texas	United States	76087
37	Retina Institute of Virginia	Richmond	Virginia	United States	23235

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Joanne Li, MD, Allergan

Study Documents (Full-Text)

• Study Protocol - Oct 16, 2018
• Statistical Analysis Plan - Jul 25, 2018

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03539549
• Other Study ID Numbers: 1771-201-008
• First Posted: May 29, 2018
• Last Update Posted: Aug 3, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Degeneration

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Abicipar Pegol 2 mg
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 Participants	123
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	78.3 (8.21)
Sex: Female, Male (Count of Participants)
Female	71 57.7%
Male	52 42.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 3.3%
Not Hispanic or Latino	119 96.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 3.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	119 96.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Best Corrected Visual Acuity (BCVA) (letters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [letters]	62.0 (12.19)
Central Retinal Thickness (CRT) (microns) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [microns]	353.1 (94.05)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Stable Vision
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

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received at least 1 administration of study treatment.

Arm/Group Title	Abicipar Pegol 2 mg
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.
Measure Participants	123
Number (95% Confidence Interval) [percentage of participants]	97.6 79.3%

2. Secondary Outcome

Title	Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
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

Outcome Measure Data

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
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.
Measure Participants	123
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	106
Number [percentage of participants]	0.9 0.7%

4. Secondary Outcome

Title	Change Form Baseline in BCVA in the Study Eye
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

Outcome Measure Data

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
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.
Measure Participants	106
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received at least 1 administration of study treatment.

Arm/Group Title	Abicipar Pegol 2 mg
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.
Measure Participants	123
Number (95% Confidence Interval) [percentage of participants]	9.8 8%

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]
Time Frame	Baseline to Week 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	Changes From Baseline in General Physical Condition as Measured Through General Physical Exam
Time Frame	Baseline to Week 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)
Time Frame	Baseline to Week 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Percentage of Participants With Change From Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)
Time Frame	Baseline to Week 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Other Pre-specified Outcome

Title	Percentage of Participants With Anti-abicipar Antibodies Measured in Serum
Time Frame	Baseline to Week 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

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
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 (%)	# Events
Total	2/123 (1.6%)
Serious Adverse Events
	Abicipar Pegol 2 mg
	Affected / at Risk (%)	# Events
Total	16/123 (13%)
Cardiac disorders
Atrial fibrillation	2/123 (1.6%)
Tachyarrhythmia	1/123 (0.8%)
Eye disorders
Iritis	1/123 (0.8%)
Retinal haemorrhage	1/123 (0.8%)
Vitreous haemorrhage	1/123 (0.8%)
Vitritis	1/123 (0.8%)
Injury, poisoning and procedural complications
Meniscus injury	1/123 (0.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/123 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	2/123 (1.6%)
B-cell lymphoma	1/123 (0.8%)
Brain neoplasm	1/123 (0.8%)
Glioblastoma	1/123 (0.8%)
Oesophageal carcinoma	1/123 (0.8%)
Nervous system disorders
Cerebrovascular accident	1/123 (0.8%)
Dysarthria	1/123 (0.8%)
Vascular disorders
Hypertension	1/123 (0.8%)
Other (Not Including Serious) Adverse Events
	Abicipar Pegol 2 mg
	Affected / at Risk (%)	# Events
Total	0/123 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.