SAFETY AND EFFICACY OF ABICIPAR PEGOL (AGN-150998) IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATIO

Not Applicable

Recruiting

• Conditions: -H353 Degeneration of macula and posterior pole; Degeneration of macula and posterior pole; H353

• Registration Number: PER-065-15
• Lead Sponsor: Allergan, Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-22
• Study Completion: 2019-01-16
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 0

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).
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.
8. BCVA of 34 letters (Snellen equivalent 20/200) or better at baseline (day 1), prior to treatment.

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 (Section 4.5.1.1)
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).
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.
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 wi

Study & Design

• Study Type: Interventional
• Study Design: Not specified