Study to determine (find out) the Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular Degeneratio
- Conditions
- eovascular age-related macular degeneration (AMD).MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2014-004580-20-DK
- Lead Sponsor
- Allergan Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 926
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 secondary to AMD with 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
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 iodine
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 ocular/intraocular infection at baseline (day 1)
9. History of recurrent or currently active ocular/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 retinal
detachment (considered by the investigator to significantly affect central vision) prior to
baseline (day 1)
14. Previous use of verteporfin PDT or any ocular anti-angiogenic therapy (eg, aflibercept,
bevacizumab, ranibizumab, pegaptanib), approved or investigational, for the treatment of
neovascular AMD or previous therapeutic radiation in the region of the study eye
15. Any prior or current systemic or ocular treatment (including surgery) for neovascular
AMD, approved or investigational, except dietary supplements or vitamins
16. Prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD
17. Treatment with ocular corticosteroid injections or
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety and efficacy of abicipar compared with ranibizumab in treatment-naïve patients with<br>neovascular age-related macular degeneration (AMD).;Secondary Objective: Not applicable;Primary end point(s): Proportion of patients with stable vision (i.e. patients who lose fewer than 15 letters in<br>BCVA) from baseline at week 52.;Timepoint(s) of evaluation of this end point: Week 52.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Mean change from baseline in BCVA at week 52<br>- Mean change from baseline in CRT as assessed with SD-OCT and quantified by the central reading center at week 52<br>- Proportion of patients with a gain of 15 or more ETDRS letters in BCVA from baseline at week 52<br>- Mean change from baseline in NEI-VFQ-25 composite score at week 52;Timepoint(s) of evaluation of this end point: Week 52.