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Trial record 2 of 2 for:    CEDAR | wet amd

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
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration.

Condition or disease Intervention/treatment Phase
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
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.
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.
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.
Drug: ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 96.
Other Name: Lucentis®




Primary Outcome Measures :
  1. Percentage of Patients with Best Corrected Visual Acuity (BCVA) Change from Baseline ≤15 Letters in the Study Eye [ Time Frame: Baseline, Week 52 ]

Secondary Outcome Measures :
  1. Change from Baseline in BCVA in the Study Eye [ Time Frame: Baseline, Week 52 ]
  2. Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye [ Time Frame: Baseline, Week 52 ]
  3. 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 ]
  4. 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
Criteria

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

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): NCT02462928


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Sponsors and Collaborators
Allergan
Investigators
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