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

Macular Degeneration Clinical Trial

Official title:

Evaluation of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539549
• Other study ID #: 1771-201-008
• Status: Completed
• Phase: Phase 2
• Start date: May 25, 2018
• Est. completion date: February 27, 2019

Study information

• Verified date: July 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 27, 2019
• Est. primary completion date: February 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Capital Region Retina, PLLC	Albany	New York
United States	Win Retina	Arcadia	California
United States	Texas Retina Associates	Arlington	Texas
United States	Austin Retina Associates	Austin	Texas
United States	Texan Eye	Austin	Texas
United States	Gailey Eye Clinic	Bloomington	Illinois
United States	Pennsylvania Retina Specialists, P.C.	Camp Hill	Pennsylvania
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Retina Consultants of Orange County	Fullerton	California
United States	Mark B. Kislinger, MD, Inc.	Glendora	California
United States	Colorado Retina Associates	Golden	Colorado
United States	Retinal Consultants of Houston	Houston	Texas
United States	Atlantis Retina Institute (Atlantis Eyecare)	Huntington Beach	California
United States	Raj K. Maturi, MD, PC	Indianapolis	Indiana
United States	Charleston Neuroscience Institute	Ladson	South Carolina
United States	Sabates Eye Center	Leawood	Kansas
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	Georgia Retina, P.C.	Marietta	Georgia
United States	Marietta Eye Clinic	Marietta	Georgia
United States	Premiere Retina Specialists	Midland	Texas
United States	N. California Retina Vitreous Associates Medical Group, INC.	Mountain View	California
United States	California Eye Specialists Medical Group, Inc	Pasadena	California
United States	Retina Specialty Institute	Pensacola	Florida
United States	Barnet Dulaney Perkins Eye Center	Phoenix	Arizona
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Sierra Eye Associates	Reno	Nevada
United States	Retina Institute of Virginia	Richmond	Virginia
United States	Retina Associates of Western New York	Rochester	New York
United States	Retinal Consultants Medical Group, Inc.	Sacramento	California
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	Retinal Consultants of San Antonio	San Antonio	Texas
United States	Retina Vitreous Surgeons of Central NY, P.C.	Syracuse	New York
United States	Retina Consultants of Houston	The Woodlands	Texas
United States	Retina Associates Southwest, PC	Tucson	Arizona
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Changes From Baseline in General Physical Condition as Measured Through General Physical Exam		Baseline to Week 28
Other	Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)		Baseline to Week 28
Other	Percentage of Participants With Change From Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)		Baseline to Week 28
Other	Percentage of Participants With Anti-abicipar Antibodies Measured in Serum		Baseline to Week 28
Primary	Percentage of Participants With Stable Vision	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.	Baseline (Day 1) to Week 28
Secondary	Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	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.	Baseline (Day 1) to Week 28
Secondary	Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye	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.	Baseline (Day 1) to Week 28
Secondary	Change Form Baseline in BCVA in the Study Eye	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.	Baseline (Day 1) to Week 28
Secondary	Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye	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.	Baseline (Day 1), Week 28