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    Clinical Trial Results:
    A Randomized, Double-masked, Sham-controlled Phase 4 Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in patients with Polypoidal Choroidal Vasculopathy (ATLANTIC)

    Summary
    EudraCT number
    		 2015-001368-20
    Trial protocol
    		 PT   ES  
    Global end of trial date
    05 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2021
    First version publication date
    27 Oct 2021
    Other versions
    Summary report(s)
    		 StudyReport Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    ECR-AMD-2015-09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02495181
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AIBILI
    Sponsor organisation address
    Edifício Prof. Doutor José Cunha-Vaz, Azinhaga de Santa Comba, Celas, Coimbra, Portugal, 3000-548
    Public contact
    Sónia Simões, AIBILI - Association for Innovation and Biomedical Research on Light and Image, atlantic@aibili.pt
    Scientific contact
    Rufino Silva, AIBILI - Association for Innovation and Biomedical Research on Light and Image, rufino.silva@oftalmologia.co.pt
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of Aflibercept with and without PDT in AMD patients diagnosed with PCV, by: 1- Comparing best corrected visual acuity (BCVA) changes at Week 52 in AMD patients with PCV treated with Aflibercept associated with verteporfin PDT versus BCVA in AMD patients with PCV treated with Aflibercept associated with sham PDT. 2- Comparing polyps regression at Week 52 in AMD patients with PCV treated with Aflibercept associated with verteporfin PDT versus polyps regression in AMD patients with PCV treated with Aflibercept associated with sham PDT. Polyps regression has been defined as a reduction in the total area of polyps, as assessed by the Central Reading Centre.
    Protection of trial subjects
    This study was designed, implemented and reported in accordance with the ICH Harmonized Tripartite E6 (R2), Guidelines for Good Clinical Practice, with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21 and Japanese Ministry of Health, Labor, and Welfare) and with the ethical principles laid down in the Declaration of Helsinki. The Principal Investigators and all clinical study staff conducted the clinical study in compliance with the protocol. The Principal Investigators ensured that all personnel involved in the conduct of the study were qualified to perform their assigned responsibilities through relevant education, training and experience. Patients only performed any of the study procedures after providing written IRB/IEC approved informed consent, or, if incapable of doing so, after such consent has been provided by a legally acceptable representative of the patient or witnessed, where required by law or regulation. In cases where the patient’s representative gave consent, the patient has been informed about the study to the extent possible given his/her understanding. If the patient was capable of doing so, he/she indicated assent by personally signing and dating the written informed consent document. The process of obtaining informed consent has been documented in the patient source documents. The Investigator ensured that each patient was fully informed about the nature and objective of the study and possible risks and benefits associated with participation. The Investigator kept in the study investigator file the original of each patient’s signed informed consent form and gave a copy to the patient.
    Background therapy
    		 If patient’s eligibility was confirmed, patients received one intravitreal injection of Aflibercept, 2 mg, (IVA) per month for three consecutive doses at weeks 0, 4 and 8 (loading phase). Patients returned for treatment at Week 16 and they were randomized, according to stratification by polyps’ activity as indicated by ICGA, (1:1): to one of the following groups, - Group 1: Intravitreal Injection of Aflibercept 2 mg T&E + Verteporfin PDT - Group 2: Intravitreal Injection of Aflibercept 2 mg T&E + Sham PDT Note: - At Week 16 all patients received IVA. PDT was only applied if presence of active polyps was confirmed on the ICGA. - The need of PDT was also assessed on Weeks 28 and 40. - Frequency of IVA was assessed on Weeks 16, 28 and 40.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jan 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Portugal: 42
    Country: Number of subjects enrolled
    Spain: 8
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    13
    From 65 to 84 years
    33
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study population consisted of male and female subjects older than 50 years-old with Age-related Macular Degeneration (AMD) and naive Polypoidal Choroidal Vasculopathy (PCV).

    Pre-assignment
    Screening details
    		 Only treatment-naive patients, 50 years of age or older, were recruited. Only eyes with a BCVA ETDRS letter score at study entry of 25 to 80 letters, and greatest linear dimension of the lesion of 5400 μm or less as assessed by fluorescein angiography and ICGA were included. 86 patients were screened, 36 of which failed the inclusion criteria.

    Period 1
    Period 1 title
    Baseline - Week 0 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The Study Medication Aflibercept was open label, so unblinding was not applicable for Aflibercept. PDT was double-masked. The Investigator Sponsor and subject were not aware of the treatment being administered in case of PDT. The Monitor and Project Manager were unblinded. The double-blinding of the PDT was maintained throughout the conduction of the study. Only once all study data have been verified and the database locked, individual subjects were unblinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IVA + Verteporfin PDT
    Arm description
    		 Intravitreal Injection of Aflibercept 2 mg T&E + Verteporfin PDT
    Arm type
    		 Experimental

    Investigational medicinal product name
    AFLIBERCEPT+ VERTEPORFIN
    Investigational medicinal product code
    S01LA05 + S01LA01
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    40 mg/ml AFLIBCERPT + 2 mg/ml verteporfin

    Arm title
    		 IVA + Sham PDT
    Arm description
    		 Intravitreal Injection of Aflibercept 2 mg T&E + Sham PDT
    Arm type
    		 Active comparator

    Investigational medicinal product name
    AFLIBERCEPT + SHAM
    Investigational medicinal product code
    S01LA05
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    40 mg/ml AFLIBCERPT + 5% dextrose solution

    Number of subjects in period 1
    		IVA + Verteporfin PDT IVA + Sham PDT
    Started
    28
    22
    Completed
    28
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline - Week 0
    Reporting group description
    		 PCV cohort

    Reporting group values
    		 Baseline - Week 0 Total
    Number of subjects
    		 50 50
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 13 13
        From 65-84 years
    		 33 33
        85 years and over
    		 4 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.14 ( 9.17 ) -
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 25 25
    Polyps
    Presence of polypoidal lesions
    Units: Subjects
        Presence
    		 50 50
    BCVA
    Baseline BCVA
    Units: ETDRS letters
        median (inter-quartile range (Q1-Q3))
    		 66 (56 to 70) -

    End points

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    End points reporting groups
    Reporting group title
    IVA + Verteporfin PDT
    Reporting group description
    		 Intravitreal Injection of Aflibercept 2 mg T&E + Verteporfin PDT

    Reporting group title
    IVA + Sham PDT
    Reporting group description
    		 Intravitreal Injection of Aflibercept 2 mg T&E + Sham PDT

    Subject analysis set title
    Study population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients included were analysed.

    Primary: Change in BCVA

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    End point title
    		 Change in BCVA
    End point description
    Change in BCVA from Baseline to week 52 (1-year)
    End point type
    Primary
    End point timeframe
    From baseline to 1 year
    End point values
    		 IVA + Verteporfin PDT IVA + Sham PDT Study population
    Number of subjects analysed
    28
    22
    50
    Units: ETDRS letters
        median (inter-quartile range (Q1-Q3))
    5 (2 to 13)
    6.5 (2 to 11)
    6 (2 to 12)
    Statistical analysis title
    		 Change in BVCA
    Statistical analysis description
    Change in BCVA from Baseline to Week 52
    Comparison groups
    IVA + Sham PDT v IVA + Verteporfin PDT
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.98
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1
    Notes
    [1] - Proof of concept analysis due to small sample size

    Primary: Complete polyp occlusion

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    End point title
    		 Complete polyp occlusion
    End point description
    End point type
    Primary
    End point timeframe
    At week 52 (1 year).
    End point values
    		 IVA + Verteporfin PDT IVA + Sham PDT Study population
    Number of subjects analysed
    28
    22
    50
    Units: Number of subjects
    17
    17
    34
    Statistical analysis title
    		 Complete polyp occlusion
    Statistical analysis description
    Complete polyp occlusion at week 52
    Comparison groups
    IVA + Verteporfin PDT v IVA + Sham PDT
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.53 [3]
    Method
    		 Fisher exact
    Parameter type
    		 none
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1
    Notes
    [2] - Proof of concept analysis due to small sample size
    [3] - Results for the primary objectives (i.e, change in BCVA from baseline to week 52, and polyp occlusion at week 52) were considered statistically significant if a test reached an α level of 0.025

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety results during the follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    IVA + Verteporfin PDT
    Reporting group description
    		 Intravitreal Injection of Aflibercept 2 mg T&E + Verteporfin PDT

    Reporting group title
    IVA + Sham PDT
    Reporting group description
    		 Intravitreal Injection of Aflibercept 2 mg T&E + Sham PDT

    Serious adverse events
    		 IVA + Verteporfin PDT IVA + Sham PDT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 22 (4.55%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Vulval cancer
    Additional description: Vulvar skin cancer
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardiac pacemaker insertion
    Additional description: Auricular fibrillation with pacemaker implantation
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
    Additional description: Abdominal hernia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 IVA + Verteporfin PDT IVA + Sham PDT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 28 (57.14%)
    9 / 22 (40.91%)
    Vascular disorders
    blood pressure high
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Vasculitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Hypertension
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Systolic hypertension
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Hypertensive crisis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    retrosternal pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    allergic reaction to antibiotics
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Productive cough
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    expectoration
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Investigations
    intraocular pressure high
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 22 (4.55%)
         occurrences all number
    1
    2
    Injury, poisoning and procedural complications
    fractured metatarsal
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Stress fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Procedural dizziness
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    finger traumatic amputation
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    facial neuralgia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    vasovagal reaction
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Inner ear disorder
    Additional description: Vertigo
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    wax in ear
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    deafness left ear
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Ocular hypertension
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    visual acuity decreased
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Eye pain
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 22 (9.09%)
         occurrences all number
    3
    2
    Retinal pigment epithelial tear
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Posterior capsule opacification
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Blepharitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    Keratitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    red eye
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    abdonimal pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Odynophagia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    Nausea
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    urinary incontinence aggravated
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    osteoarticular pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Groin pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    backache
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
    Additional description: Influenza viral infection
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 22 (9.09%)
         occurrences all number
    1
    3
    Respiratory tract infection
    Additional description: Respiratory tract infection - pathogen unspecified
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Herpes zoster
    Additional description: Herpes viral infections
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Herpes ophthalmic
    Additional description: Herpes opthalmic Left Eye
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Conjunctivitis
    Additional description: Conjunctivitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Otitis media
    Additional description: Ear infection - otitis media
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
    Additional description: Abdominal and gastrointestinal infections - pathogen unspecified
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
    Additional description: Nasopharyngitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Dyslipidaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jun 2015
    In Inclusion Criteria Number 5, 5400 mm was corrected to 5400 µm.
    20 Aug 2015
    Inclusion/exclusion criteria and rescue treatment criteria were updated
    21 Mar 2018
    Addition of a new procedure (blood collection for genetic analysis) and updating blinding and unbliding procedures.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    low statistical power of the sample size and only one-year of follow-up

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34348351
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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