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Evaluating Abicipar for Safety and Treatment Effect in Patients With Neovascular Age-related Macular Degeneration (AMD)

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ClinicalTrials.gov Identifier: NCT03539549
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
The objective of this study is to evaluate abicipar for safety and treatment effect in patients with neovascular Age-related Macular Degeneration (AMD).

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Abicipar pegol Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating Abicipar for Safety and Treatment Effect in Patients With Neovascular Age-related Macular Degeneration (AMD)
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : April 23, 2019
Estimated Study Completion Date : April 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Abicipar pegol
2 mg abicipar administered to the study eye by intravitreal injections
Drug: Abicipar pegol
2 mg abicipar administered to the study eye by intravitreal injections at baseline (Day 1) and Weeks 4, 8, 16, and 24




Primary Outcome Measures :
  1. Change from Baseline in Best Corrected Visual Acuity ( BCVA) in the study eye using Early-Treatment Diabetic Retinopathy study (ETDRS) Scale [ Time Frame: Baseline to week 28 ]
  2. 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 ]
  3. Changes from Baseline in General Physical Condition as Measured through General Physical Exam [ Time Frame: Baseline to Week 28 ]
  4. Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG) [ Time Frame: Baseline to Week 28 ]
  5. Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) [ Time Frame: Baseline to Week 28 ]
  6. Percentage of Participants with anti-abicipar antibiodies measured in serum [ Time Frame: Baseline to Week 28 ]

Secondary Outcome Measures :
  1. Change from Baseline in Central Retinal Thickness (CRT) in the Study eye [ Time Frame: Baseline to week 24 ]
  2. Percentage of Patients with Best Corrected Visual Acuity (BCVA) Change from Baseline ≤15 Letters in the Study Eye [ Time Frame: Baseline to Week 28 ]
  3. Change from Baseline in BCVA in the Study Eye [ Time Frame: Baseline to Week 28 ]
  4. 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 to Week 28 ]
  5. Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye [ Time Frame: Baseline to Week 28 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients, 50 years of age or older at the time of informed consent
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539549


Contacts
Contact: Clinical Trials Registry Team 877‐277‐8566 IR‐CTRegistration@Allergan.com

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Sponsors and Collaborators
Allergan
Investigators
Study Director: Joanne Li, MD Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03539549     History of Changes
Other Study ID Numbers: 1771-201-008
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases