Allergan SEQUOIA

Principal Investigator: Paul Bernstein
Keywords: Age-related macular degeneration Department: Ophthalmology-Services
IRB Number: 00085510 Co Investigator:  
Specialty: Ophthalmology, Ophthalmology
Sub Specialties: Retinal Diseases, Geriatric Ophthalmology
Recruitment Status: Active, not recruiting

Contact Information

Susan Allman
susan.allman@hsc.utah.edu
801-581-5142

Brief Summary

Study Objective:
To assess the safety and efficacy of abicipar compared with ranibizumab in treatment-naïve patients with neovascular age-related macular degeneration (AMD)
 
Clinical Hypotheses:
• Multiple intravitreal injections of 2 mg abicipar have an acceptable safety profile in treatment-naïve
patients with neovascular AMD
• The efficacy of at least 1 of the 2 abicipar regimens is non-inferior to that of monthly ranibizumab
intravitreal injections as assessed by the proportion of patients with stable vision1 at week 52

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)

  1. 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)
  2. 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)
  3. BCVA ≤ 73 and ≥ 24 letters (20/40 to 20/320 Snellen equivalents, respectively) at screening and at baseline (day 1, prior to treatment) visits
  4. Sufficiently clear ocular media and adequate pupil dilation to permit good quality photographic imaging

Ocular Inclusion Criteria (Non-study Eye)

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

 

 

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)

  1. Active periocular, ocular or intraocular infection at baseline (day 1)
  2. History of recurrent or currently active ocular or intraocular inflammation (eg, uveitis) at baseline (day 1)
  3. 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)

  1. Presence of CNV other than AMD at screening, eg, pathologic myopia, ocular histoplasmosis, and angioid streaks
  2. Spherical equivalent of the refractive error of -8 diopters of myopia or worse (prior to cataract or refractive surgery) at screening
  3. 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)
  4. Previous use of verteporfin photodynamic therapy 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
  5. Any prior or current systemic or ocular treatment (including surgery) for neovascular AMD, approved or investigational, except dietary supplements or vitamins
  6. Prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD
  7. Treatment with ocular corticosteroid injections or implants (eg, by subconjunctival, periocular, or intravitreal routes of administration) within 6 months prior to baseline (day 1), or with fluocinolone acetonide implant (Iluvien™) within 36 months prior to baseline (day 1)
  8. Previous or concurrent macular laser treatment 
  9. Total lesion size > 12 disc area (DA) (30.5 mm2 including blood, neovascularization, and fibrosis) as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1)
  10. Presence of a retinal pigment epithelium (RPE) tear or rip lesion involving the macula as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1)
  11. Structural damage to the center of the macula that is likely to preclude improvement in BCVA, as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1), including any of the following:
    • Macular hole stage 3 or 4
    • Atrophy of the RPE
    • Retinal fibrosis or scarring
  12. Macular scar or fibrosis, making up > 50% of total lesion area as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1)
  13. Macular hemorrhage that involves the center of the fovea, if the size of hemorrhage is either > 50% of the total lesion area or > 1 DA in size as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1)
  14. Vitreomacular traction or epiretinal membrane as assessed by the investigator to significantly affect central vision at screening and confirmed by the central reading center prior to baseline (day 1)
  15. History or evidence of the following surgeries at any time unless specified: 
    1. Pars plana vitrectomy (PPV)
    2. Submacular surgery or other surgical interventions for AMD
    3. Incisional glaucoma surgery
    4. Cataract or refractive surgery (excluding yttrium aluminum garnet [YAG] laser posterior capsulotomy) within the last 3 months prior to baseline (day 1)
  16. Uncontrolled glaucoma or ocular hypertension (defined as intraocular pressure [IOP] ≥ 25 mm Hg despite treatment with ocular hypotensive medications) at screening and confirmed at baseline (day 1)
  17. Aphakia or absence of the posterior capsule, or violation of the posterior capsule, unless the violation occurred as a result of YAG laser posterior capsulotomy, performed more than 1 month before baseline (day 1)
  18. Any concurrent ocular or intraocular condition which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedure of intraocular injections, or which otherwise may interfere with the injection procedure or evaluation of efficacy or safety