Study to determine (find out) the Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular Degeneration

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2014-004579-22-AT
• Date of registration: 15/06/2015
• Prospective Registration: Yes
• Primary sponsor: Allergan Ltd.
• Public title: Study to determine (find out) the Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular Degeneration
• Scientific title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular Degeneration - CEDAR
• Date of first enrolment: 14/07/2015
• Target sample size: 926
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004579-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Austria, Chile, Colombia, Czech Republic, France, Germany, Hong Kong, Israel, Korea, Republic of, Latvia, New Zealand, Philippines, Portugal, Singapore, Spain, Switzerland, United States

Contacts

• Name: Allergan Limited EU Regulatory Dept
• Affiliation: Allergan Limited

• Name: Allergan Limited EU Regulatory Dept
• Affiliation: Allergan Limited

Key inclusion & exclusion criteria

Inclusion criteria:
General Inclusion Criteria
1. Male or female patients, 50 years of age or older at the time of informed consent
2. Patient has completed/signed an informed consent prior to conduct of any study-related
procedures or examinations, is able to follow study instructions, and is likely to complete
all required visits
3. Patient has provided, at screening, written documentation in accordance with the relevant
country and local privacy requirements (eg, Written Authorization for Use and Release of Health and Research Study Information and written Data Protection consent, as required
by regional health authorities)

Ocular Inclusion Criteria (Study Eye)
4. Presence of active subfoveal and/or juxtafoveal CNV (1 to 200 micron
from the center) secondary to AMD assessed by fluorescein angiogram.
In addition, presence of retinal fluid on optical coherence tomography (OCT) and/or fluorescein leakage under the fovea as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1)
5. Area of the CNV lesion, including both classic and occult components, must be > 50% of
the total lesion area as assessed by the investigator at screening and confirmed by the
central reading center prior to baseline (day 1)
6. BCVA = 73 and = 24 letters (20/40 to 20/320 Snellen equivalents, respectively) at
screening and at baseline (day 1, prior to treatment) visits
7. Sufficiently clear ocular media and adequate pupil dilation to permit good quality
photographic imaging

Ocular Inclusion Criteria (Non-study Eye)
8. BCVA of 34 letters (Snellen equivalent 20/200) or better at baseline (day 1), prior to treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 308
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 618

Exclusion criteria:
General Exclusion Criteria
1. Females who are pregnant, nursing, planning a pregnancy during the study, or who are of
childbearing potential and not using a reliable method of contraception and/or not willing to use a reliable method of contraception during their participation in
the study. A pregnancy test administered to women of childbearing potential at the
baseline visit (day 1, prior to treatment) must be negative for the patient to receive study
medication
2. History or current evidence of hypersensitivity to any components of the study
medication or clinically relevant sensitivity to fluorescein, as assessed by the investigator
at screening
3. History or current evidence of hypersensitivity, allergy, or anaphylactic reaction to povidone iodine solution
as assessed by the investigator at screening
4. Participation in any investigational device study within 30 days, or participation in any
investigational drug study within 30 days or 5 half-lives of the respective investigational
drug (whichever is longer) prior to baseline (day 1)
5. History or current evidence of a medical condition (including physical examination
finding, or clinical laboratory finding) that may, in the opinion of the investigator,
preclude the safe administration of study medication, adherence to the scheduled study
visits, safe participation in the study or confound study results (eg, metabolic
dysfunction, uncontrolled hypertension, autoimmune disease, infection, inflammatory
condition, advanced coronary artery disease, cerebral vascular disease, other unstable or
progressive cardiovascular or pulmonary condition, Parkinson's disease, liver or renal
failure, cancer, or dementia)
6. Treatment with systemic anti-VEGF medication (eg, bevacizumab, ziv-aflibercept) or
VEGF-receptor inhibitor (eg, sunitinib, sorafenib, pazopanib) within 3 months prior to
baseline (day 1)
7. Use of systemic (eg, oral, intravenous, intramuscular, rectal), or extensive dermal (> 20%
total body surface area) corticosteroids within 5 days prior to baseline (day 1)

Ocular Exclusion Criteria (Either Eye)
8. Active periocular, ocular or intraocular infection at baseline (day 1)
9. History of recurrent or currently active ocular or intraocular inflammation (eg, uveitis) at
baseline (day 1)
10. History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME) or
any retinal vascular disease other than AMD at screening

Ocular Exclusion Criteria (Study Eye)
11. Presence of CNV other than AMD at screening, eg, pathologic myopia, ocular
histoplasmosis, and angioid streaks
12. Spherical equivalent of the refractive error of -8 diopters of myopia or worse (prior to
cataract or refractive surgery) at screening
13. Any active iris neovascularization, or current evidence of vitreous hemorrhage, or

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Neovascular age-related macular degeneration (AMD).

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

Product Name: Abicipar pegol
Product Code: AGN-150998
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Abicipar Pegol
Current Sponsor code: AGN-150998
Other descriptive name: Abicipar
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Ocular use

Trade Name: Lucentis®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Other descriptive name: RANIBIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Secondary Objective: Not Applicable

Main Objective: To assess the safety and efficacy of abicipar compared with ranibizumab in treatment-naïve patients with
neovascular age-related macular degeneration (AMD).

Primary end point(s): Proportion of patients with stable vision (i.e. patients who lose fewer than 15 letters in
BCVA) from baseline at week 52.

Timepoint(s) of evaluation of this end point: Week 52.

Secondary Outcome(s)

Secondary end point(s): - Mean change from baseline in BCVA at week 52
- Mean change from baseline in CRT as assessed with SD-OCT and quantified by the central reading center at week 52
- Proportion of patients with a gain of 15 or more ETDRS letters in BCVA from baseline at week 52
- Mean change from baseline in NEI-VFQ-25 composite score at week 52

Timepoint(s) of evaluation of this end point: Week 52.

Secondary ID(s)

150998-005

2014-004579-22-CZ

Source(s) of Monetary Support

Allergan Limited

Ethics review

Status: Approved
Approval date:
Contact: