A Safety and Efficacy Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration (CDER)
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ClinicalTrials.gov Identifier: NCT02462928 |
Recruitment Status :
Active, not recruiting
First Posted : June 4, 2015
Last Update Posted : May 1, 2018
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Condition or disease | Intervention/treatment | Phase |
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Macular Degeneration | Drug: abicipar pegol Drug: ranibizumab Other: sham procedure | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 939 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration |
Actual Study Start Date : | June 25, 2015 |
Actual Primary Completion Date : | April 18, 2018 |
Estimated Study Completion Date : | May 31, 2019 |

Arm | Intervention/treatment |
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Experimental: abicipar pegol 2 mg (group A)
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on day 1, week 4, and week 8, followed by injections every 8 weeks through week 96. A sham procedure to the study eye will be performed every 4th week that an injection of abicipar pegol is not performed.
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Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol. Other: sham procedure Sham procedure to the study eye at the visits noted per protocol. |
Experimental: abicipar pegol 2 mg (group B)
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on day 1, week 4, and week 12, followed by injections every 12 weeks through week 96. A sham procedure to the study eye will be performed every 4th week that an injection of abicipar pegol is not performed.
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Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol. Other: sham procedure Sham procedure to the study eye at the visits noted per protocol. |
Active Comparator: ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 96.
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Drug: ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 96.
Other Name: Lucentis® |
- Percentage of Patients with Best Corrected Visual Acuity (BCVA) Change from Baseline ≤15 Letters in the Study Eye [ Time Frame: Baseline, Week 52 ]
- Change from Baseline in BCVA in the Study Eye [ Time Frame: Baseline, Week 52 ]
- Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye [ Time Frame: Baseline, Week 52 ]
- 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, Week 52 ]
- Change from Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score [ Time Frame: Baseline, Week 52 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of age-related macular degeneration in at least 1 eye
- Best corrected visual acuity of 20/40 to 20/320 in the study eye
- Best corrected visual acuity of 20/200 or better in the non-study eye
Exclusion Criteria:
- History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
- Cataract or refractive surgery in the study eye within the last 3 months

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): NCT02462928

Study Director: | Ying Wang | Allergan |
Additional Information:
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT02462928 History of Changes |
Other Study ID Numbers: |
150998-005 2014-004579-22 ( EudraCT Number ) CEDAR ( Other Identifier: Allergan ) |
First Posted: | June 4, 2015 Key Record Dates |
Last Update Posted: | May 1, 2018 |
Last Verified: | April 2018 |
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 Ranibizumab Immunologic Factors |
Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |