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A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD]

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ClinicalTrials.gov Identifier: NCT04270747
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : July 8, 2021
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE February 13, 2020
First Posted Date  ICMJE February 17, 2020
Last Update Posted Date July 8, 2021
Actual Study Start Date  ICMJE June 22, 2020
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2020)
Change from Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: At week 8 ]
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 8.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2021)
  • Change from Baseline in ETDRS letter score at week 52 maintaining vision lost fewer than 15 letters [ Time Frame: At week 52 ]
    Proportion of subjects who maintained vision at week 52, where a subject was classified as maintaining vision if he/she lost fewer than 15 letters in ETDRS letter score compared to Baseline.
  • Change from Baseline in BCVA [ Time Frame: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52 ]
    Change from Baseline in BCVA as measured by ETDRS letter score over the study duration.
  • Change from Baseline in ETDRS letter score at week 8 and week 52 [ Time Frame: At week 8 and week 52 ]
    Proportion of subjects who gained at least 10 letters of vision at week 8 and proportion of subjects who gained at least 15 letters of vision at week 52 as compared to Baseline.
  • Change from Baseline in Choroidal Neovascularization (CNV) area [ Time Frame: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52 ]
    Change from Baseline in CNV area as measured by Fluorescein Angiography (FA) over the study duration
  • Change from Baseline in Central Subfield Thickness (CST) [ Time Frame: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52 ]
    Change from Baseline in CST as measured by spectral domain optical coherence tomography (SD-OCT) over the study duration
  • Number of subjects with incidence of Antidrug Antibodies (ADA) [ Time Frame: At day 1, week 8, week 16, week 24, week 40 and week 52 ]
  • Number of subjects with treatment-emergent adverse events, adverse events of interest (EOIs), and serious adverse events [ Time Frame: Upto 56 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2020)
  • Change from Baseline in ETDRS letter score at week 52 maintaining vision lost fewer than 15 letters [ Time Frame: At week 52 ]
    Proportion of subjects who maintained vision at week 52, where a subject was classified as maintaining vision if he/she lost fewer than 15 letters in ETDRS letter score compared to Baseline.
  • Change from Baseline in BCVA [ Time Frame: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52 ]
    Change from Baseline in BCVA as measured by ETDRS letter score over the study duration.
  • Change from Baseline in ETDRS letter score at week 8 and week 52 [ Time Frame: At week 8 and week 52 ]
    Proportion of subjects who gained at least 10 letters of vision at week 8 and proportion of subjects who gained at least 15 letters of vision at week 52 as compared to Baseline.
  • Change from Baseline in Choroidal Neovascularization (CNV) area [ Time Frame: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52 ]
    Change from Baseline in CNV area as measured by Fluorescein Angiography (FA) and spectral domain optical coherence tomography (SD-OCT) over the study duration
  • Change from Baseline in Central Subfield Thickness (CST) [ Time Frame: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52 ]
    Change from Baseline in CST as measured by FA and SD-OCT over the study duration
  • Number of subjects with incidence of Antidrug Antibodies (ADA) [ Time Frame: At day 1, week 8, week 16, week 24, week 40 and week 52 ]
  • Number of subjects with treatment-emergent adverse events, adverse events of interest (EOIs), and serious adverse events [ Time Frame: Upto 56 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD]
Official Title  ICMJE A Randomized, Double-masked, Phase 3 Study of ABP 938 Efficacy and Safety Compared to Aflibercept (Eylea®) in Subjects With Neovascular Age-related Macular Degeneration
Brief Summary The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by intravitreal (IVT) injection.
Detailed Description

Approximately 566 subjects will be randomized in approximately 126 global sites.

This study consists of a screening period of up to 4 weeks, after which subjects will receive investigational product for 48 weeks, followed by a safety follow-up period to week 52, for a total study duration of up to 56 weeks.

Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by IVT injection.

At week 8, subjects will be assessed for the primary endpoint. The primary endpoint is the change in Best Corrected Visual Acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline to week 8, in order to assess the efficacy of ABP 938 compared to aflibercept.

Subjects will then be re-randomized at week 16 in a masked fashion such that:

  • Subjects initially randomized to ABP 938 (Treatment Group A) will continue to receive ABP 938 by IVT injection every 8 weeks from week 16 until week 48
  • Subjects initially randomized to aflibercept (Treatment Group B) will be re-randomized in a 1:1 ratio to either continue on aflibercept (Treatment Group B1) or transition to ABP 938 (Treatment Group B2) by IVT injection every 8 weeks from week 16 until week 48
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
The study is double-masked; therefore, the investigators, study personnel, and the study subjects will remain masked to treatment allocation. Unmasking is only allowed in the case of an emergency, when knowledge of the investigational product is essential for the clinical management of the subject.
Primary Purpose: Treatment
Condition  ICMJE Neovascular (Wet) Age-related Macular Degeneration (AMD)
Intervention  ICMJE
  • Drug: ABP 938
    Subject will receive ABP 938 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks
  • Drug: Aflibercept
    Subject will receive aflibercept 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks
    Other Name: Eylea®
Study Arms  ICMJE
  • Experimental: ABP 938-Treatment Group A
    Subjects will receive 2 mg (0.05 mL) of ABP 938 by intravitreal (IVT) injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8) and every 8 weeks from week 16 until week 48.
    Intervention: Drug: ABP 938
  • Active Comparator: Aflibercept-Treatment Group B
    Subjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by intravitreal (IVT) injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8).
    Intervention: Drug: Aflibercept
  • Active Comparator: Aflibercept-Treatment Group B1
    Subjects initially randomized to aflibercept (Treatment Group B) will be re-randomized to receive aflibercept by IVT injection every 8 weeks from week 16 until week 48
    Intervention: Drug: Aflibercept
  • Experimental: ABP 938-Treatment group B2
    Subjects initially randomized to aflibercept (Treatment Group B) will be re-randomized to receive ABP 938 by IVT injection every 8 weeks from week 16 until week 48
    Intervention: Drug: ABP 938
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2020)
566
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects or their legally authorized representative must sign an Institutional Review Board/Independent Ethics Committee approved informed consent form before any study-specific procedures
  • Men or women ≥ 50 years old
  • Subjects must be diagnosed with neovascular (wet) AMD in the study eye
  • Active treatment naïve subfoveal CNV lesions secondary to neovascular (wet) AMD including juxtafoveal lesions that affect the fovea as confirmed with SD OCT, FA and/or Fundus Photography (FP) in the study eye
  • BCVA between 73 and 34 letters, inclusive, in the study eye using ETDRS testing
  • Presence of intra and/or subretinal fluid as identified by SD-OCT attributable to active CNV in the study eye
  • Central retinal thickness of > 270µm in the study eye as measured by the machine, calculated average thickness in the central 1 mm subfield (CST) by SD-OCT at screening

Exclusion Criteria:

Subjects are excluded if they meet any of the following criteria in the study eye:

  • Total lesion size > 12 disc areas (30.5 mm^2, including blood, scars, and neovascularization) in the study eye
  • Active CNV area (classic plus occult components) that is < 50% of the total lesion area in the study eye
  • Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
  • Presence of retinal pigment epithelium tears or rips involving the macula in the study eye
  • History of any vitreous hemorrhage within 4 weeks before randomization in the study eye
  • Presence of other causes of CNV, including pathologic myopia (spherical equivalent of 8 diopters or more negative or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye
  • Prior vitrectomy or laser surgery of the macula (including photodynamic therapy or focal laser photocoagulation) in the study eye
  • History of retinal detachment in the study eye
  • Any history of macular hole of stage 2 and above in the study eye
  • Any macular pathology that might limit vision i.e., Vitreomacular traction or significant epiretinal membrane in the study eye
  • Any intraocular or periocular surgery within 3 months before randomization on the study eye, except lid surgery, which may not have taken place within 4 weeks before randomization, as long as it is unlikely to interfere with the injection
  • Prior trabeculectomy or other filtration surgery in the study eye
  • Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye
  • Aphakia or pseudophakia with complete absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] posterior capsulotomy) in the study eye
  • Previous therapeutic radiation in the region of the study eye
  • History of corneal transplant or corneal dystrophy in the study eye
  • Significant media opacities, including cataract, which might interfere with visual acuity or assessment of safety, in the study eye
  • Any concurrent intraocular condition other than neovascular (wet) AMD in the study eye that, in the opinion of the investigator, requires planned medical or surgical intervention during the study or increases the risk to the subject beyond what is expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety

Subjects are excluded if they meet any of the following criteria in either eye:

  • History or clinical evidence of uveitis, diabetic retinopathy, diabetic macular edema, or any other vascular disease affecting the retina, other than neovascular (wet) AMD
  • Active intraocular inflammation or active or suspected ocular or periocular infection, within 2 weeks before randomization
  • Active scleritis or episcleritis or presence of scleromalacia

Other Medical Conditions

• Active extraocular infection or history of extraocular infections as follows: A. any active infection for which systemic anti-infectives were used within 4 weeks before randomization B. recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject

  • Acute coronary event or stroke within 3 months before randomization
  • Uncontrolled, clinically significant systemic disease such as diabetes mellitus, hypertension, cardiovascular disease including moderate to severe heart failure (New York Heart Association class III/IV), renal disease, or liver disease
  • Malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma

Washouts and Nonpermitted Treatments

  • Any prior ocular or systemic treatment, including another investigational product or surgery for neovascular (wet) AMD (including anti vascular endothelial growth factor [VEGF] therapy) in the study eye, except dietary supplements or vitamins
  • Any ocular or systemic treatment including another investigational product or surgery for neovascular (wet) AMD (including anti VEGF therapy) in the fellow eye, within 30 days before randomization, except dietary supplements or vitamins
  • Prior systemic anti-VEGF treatment as follows:
  • Investigational or approved anti-VEGF therapy systemically within 3 months before randomization
  • Aflibercept, ziv-aflibercept, or a biosimilar of aflibercept/ziv-aflibercept systemically at any time
  • Any IVT therapy, including adrenocorticotropic hormone, in the study or fellow eye, or intramuscular or intravenous corticosteroids within 4 weeks before randomization. The use of long-acting steroids, either systemically or intraocularly, in the 3 months before randomization
  • Currently receiving treatment with another investigational device or study drug, or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded

General

  • For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 3 months after the last dose of investigational product
  • Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo Provera injections, contraceptive implants, or other effective methods) while on study and for 3 months after the last dose of study drug. Male subjects must agree not to donate sperm during study and for 3 months following treatment with test article or until the scheduled end of the study (whichever is longer)
  • Allergy or hypersensitivity to investigational product, to any of the excipients of ABP 938 or aflibercept, or to other study-related procedures/medications (eg, anesthesia, antiseptic, fluorescein dye)
  • History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries  ICMJE Canada,   Czechia,   Estonia,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Poland,   Slovakia,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04270747
Other Study ID Numbers  ICMJE 20170542
2019-002503-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Parexel
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP