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

NCT03539549 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1771-201-008
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 37

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).

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Baseline (Day 1) to Week 28

• 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

• Change Form Baseline in BCVA in the Study Eye

  Baseline (Day 1) to Week 28

• 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

Other Outcomes (5)

• 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

• Changes From Baseline in General Physical Condition as Measured Through General Physical Exam

  Baseline to Week 28

• Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)

  Baseline to Week 28

Study Arms (1)

Abicipar pegol 2 mg

EXPERIMENTAL

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

Interventions

Abicipar pegol DRUG

Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.

Abicipar pegol 2 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Allergan: lead

Study Sites (37)

Barnet Dulaney Perkins Eye Center

Phoenix, Arizona, 85016, United States

Location

Retina Associates Southwest, PC

Tucson, Arizona, 85710, United States

Location

Win Retina

Arcadia, California, 91006, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Mark B. Kislinger, MD, Inc.

Glendora, California, 91741, United States

Location

Atlantis Retina Institute (Atlantis Eyecare)

Huntington Beach, California, 92647, United States

Location

N. California Retina Vitreous Associates Medical Group, INC.

Mountain View, California, 94040, United States

Location

California Eye Specialists Medical Group, Inc

Pasadena, California, 91107, United States

Location

Retinal Consultants Medical Group, Inc.

Sacramento, California, 95819, United States

Location

Colorado Retina Associates

Golden, Colorado, 80401, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Georgia Retina, P.C.

Marietta, Georgia, 30060, United States

Location

Marietta Eye Clinic

Marietta, Georgia, 30060, United States

Location

Gailey Eye Clinic

Bloomington, Illinois, 61704, United States

Location

Raj K. Maturi, MD, PC

Indianapolis, Indiana, 46290, United States

Location

Sabates Eye Center

Leawood, Kansas, 66211, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Capital Region Retina, PLLC

Albany, New York, 12206, United States

Location

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11580, United States

Location

Retina Associates of Western New York

Rochester, New York, 14620, United States

Location

Retina Vitreous Surgeons of Central NY, P.C.

Syracuse, New York, 13224, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Pennsylvania Retina Specialists, P.C.

Camp Hill, Pennsylvania, 17011, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Texan Eye

Austin, Texas, 78731, United States

Location

Retinal Consultants of Houston

Houston, Texas, 77030, United States

Location

Premiere Retina Specialists

Midland, Texas, 79706, United States

Location

Retinal Consultants of San Antonio

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

Retina Institute of Virginia

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

abicipar pegol

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

IR-CTRegistration@allergan.com

714-246-4500

Study Officials

• Joanne Li, MD

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 29, 2018
• Study Start: May 25, 2018
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: August 3, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (37)