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Polypoidal Choroidal VasculopathyPhase 4ATLANTICNCT02495181

Randomized, Double-masked, Sham-controlled Phase 4 Study, Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With Polypoidal Choroidal Vasculopathy

A Phase 4 study testing Intravitreal Aflibercept in people with Polypoidal Choroidal Vasculopathy, run by Association for Innovation and Biomedical Research on Light and Image at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept plus standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Polypoidal Choroidal Vasculopathy
What is being tested?
Intravitreal Aflibercept
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
13 sitesin 2 countries
Study dates
23 Nov 2015to 17 Dec 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Either gender and Age ≥ 50.
  • Naïve PCV patients.
  • Confirmed diagnosis of symptomatic macular PCV in the study eye.
  • Greatest linear dimension of the lesion of < 5400 mm, assessed by ICG angiography.
  • BCVA at study entry of 25 to 80 letters (Snellen Equivalent 20/320 to 20/25).
  • Lesion size in the study eye at study entry:
Show all 11Show fewer
  • Presence of PCV assessed by the Central Reading Centre based on ICG with active polyps with or without abnormal vascular network.
  • Women must be using effective contraception, be post-menopausal for at least
  • months prior to trial entry, or surgically sterile.
  • Ability to provide written informed consent.
  • Ability to return for all study visits.

Who cannot join

  • Active inflammation or infection in the study eye.
  • Uncontrolled intraocular pressure in the study eye.
  • Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epirretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema).
  • Presence of centromacular scarring or atrophy indicating irreversible BCVA loss.
  • Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF products within 3 months prior to the study entry.
  • Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Portugal9 sites

  • Hospital de Braga

    Braga, 4710-243

  • AIBILI - Centro de Ensaios Clínicos

    Coimbra, 3000-548 Coimbra

  • Espaço Médico de Coimbra

    Coimbra, 3030-163

  • Centro Hospitalar de Leiria

    Leiria, 2400-171

  • IRL - Instituto de Retina e Diabetes de Lisboa

    Lisbon, 1050-085 Lisboa

  • Centro Hospitgalar de Lisboa Norte, EPE - Hospital de Santa Maria

    Lisbon, 1649-035

  • Instituto de Oftalmologia Dr. Gama Pinto

    Lisbon

  • Centro Hospitalar do Porto- Hospital de Santo António

    Porto, 4099-001

  • Centro Hospitalar de São João, EPE - Serviço de Oftalmologia

    Porto, 4200-319

Other trials in Portugal

Spain4 sites

  • Bellvitge University Hospital

    Barcelona

  • Instituto de Microcirugia Ocular

    Barcelona

  • Vall d'Hebron Hospital

    Barcelona

  • Hospital Insular de Gran Canaria

    Las Palmas

Other trials in Spain

About this study

Official title: A Randomized, Double-masked, Sham-controlled Phase 4 Study of the Efficacy, Safety, and Tolerability of IV Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With PCV.

The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept plus standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV).

Read the detailed description

To compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept associated with standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV) in a proof concept study and to identify genetic biomarkers for the diagnosis and treatment response of PCV in Caucasians.

Being tested
Intravitreal Aflibercept
Medical subject headings
Polypoidal Choroidal Vasculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravitreal AfliberceptDrug

    Also called standard photodynamic therapy (PDT)

Study groups in NCT02495181
Study groupRoleWhat they receive
Aflibercept MonotherapySham comparatorIVT Aflibercept 2 mg + Sham PDT
Receives: Drug: Intravitreal Aflibercept
Aflibercept + verteporfin PDTActive comparatorIVT Aflibercept 2 mg + Verteporfin PDT
Receives: Drug: Intravitreal Aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Best Corrected Visual Acuity (BCVA)

    Unit of Measure: [Letters]

    Measured: from Baseline (Week 0) to Week 52.

  2. Polyps regression

    Unit of Measure: [Yes, No]

    Measured: from Baseline (W0) to Week 52.

Secondary outcomes (7)

  1. Polyps regression, assessed by Indocyanine Green Angiography (ICGA);

    Unit of Measure: [Yes, No]

    Measured: from Baseline (W0) to Week 16

  2. Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA);

    Unit of Measure: [Yes, No]

    Measured: from Baseline (W0) to Week 52

  3. Presence of leakage based on fluorescein angiography (FA)

    Unit of Measure: [Yes, No]

    Measured: from Baseline (W0) to Week 52

  4. Change in the Subfield Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT);

    Unit of Measure: [µm]

    Measured: from Baseline (W0) to Week 52

  5. Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52;

    Unit of Measure: [Yes, No]

    Measured: from Baseline (W0) to Week 52

  6. Total number of treatments with Aflibercept;

    Unit of Measure: [#]

    Measured: from Baseline (W0) to Week 52

  7. Frequency and severity of ocular and non-ocular adverse events over time.

    Unit of Measure: [Mild, Moderate, Severe]

    Measured: from Baseline (W0) to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2015 (estimated)
  2. Study start23 Nov 2015
  3. Primary completion22 Aug 2017
  4. Study completion17 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02495181
Sponsor's protocol ID
ECR-AMD-2015-09
Acronym
ATLANTIC
Status last verified
Feb 2019
First submitted
23 Mar 2015
Last updated
10 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • Silva R, Arias L, Nunes S, Farinha C, Coimbra R, Marques JP, Cachulo ML, Figueira J, Barreto P, Madeira MH, Pires I, Sousa JC, Distefano L, Rosa P, Carneiro A, Vaz-Pereira S, Meireles A, Cabrera F, Bures A, Mendonca L, Fernandez-Vega-Sanz A, Barrao S, Koh A, Cheung CMG, Cunha-Vaz JG, Murta J; EVICR.net ATLANTIC Study Group. Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial. Ophthalmologica. 2022;245(1):80-90. doi: 10.1159/000518235. Epub 2021 Jul 13.

    PubMed 34348351

  • Marques JP, Farinha C, Costa MA, Ferrao A, Nunes S, Silva R. Protocol for a randomised, double-masked, sham-controlled phase 4 study on the efficacy, safety and tolerability of intravitreal aflibercept monotherapy compared with aflibercept with adjunctive photodynamic therapy in polypoidal choroidal vasculopathy: the ATLANTIC study. BMJ Open. 2017 Aug 28;7(8):e015785. doi: 10.1136/bmjopen-2016-015785.

    PubMed 28851779

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravitreal Aflibercept in people with Polypoidal Choroidal Vasculopathy, run by Association for Innovation and Biomedical Research on Light and Image at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Best Corrected Visual Acuity (BCVA) (time frame: from Baseline (Week 0) to Week 52.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02495181, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.

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