NCT02495181

Brief 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 (PCV).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_4

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 23, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2017

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
Last Updated

January 10, 2020

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

March 23, 2015

Last Update Submit

January 8, 2020

Conditions

Polypoidal Choroidal Vasculopathy

Outcome Measures

Primary Outcomes (2)

  • Change in Best Corrected Visual Acuity (BCVA)

    Unit of Measure: \[Letters\]

    from Baseline (Week 0) to Week 52.

  • Polyps regression

    Unit of Measure: \[Yes, No\]

    from Baseline (W0) to Week 52.

Secondary Outcomes (7)

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

    from Baseline (W0) to Week 16

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

    from Baseline (W0) to Week 52

  • Presence of leakage based on fluorescein angiography (FA)

    from Baseline (W0) to Week 52

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

    from Baseline (W0) to Week 52

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

    from Baseline (W0) to Week 52

  • +2 more secondary outcomes

Study Arms (2)

Aflibercept Monotherapy

SHAM COMPARATOR

IVT Aflibercept 2 mg + Sham PDT

Drug: Intravitreal Aflibercept

Aflibercept + verteporfin PDT

ACTIVE COMPARATOR

IVT Aflibercept 2 mg + Verteporfin PDT

Drug: Intravitreal Aflibercept

Interventions

Intravitreal AfliberceptDRUG
Also known as: standard photodynamic therapy (PDT)
Aflibercept + verteporfin PDTAflibercept Monotherapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hospital de Braga

Braga, 4710-243, Portugal

Location

AIBILI - Centro de Ensaios Clínicos

Coimbra, 3000-548 Coimbra, Portugal

Location

Espaço Médico de Coimbra

Coimbra, 3030-163, Portugal

Location

Centro Hospitalar de Leiria

Leiria, 2400-171, Portugal

Location

IRL - Instituto de Retina e Diabetes de Lisboa

Lisbon, 1050-085 Lisboa, Portugal

Location

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

Lisbon, 1649-035, Portugal

Location

Instituto de Oftalmologia Dr. Gama Pinto

Lisbon, Portugal

Location

Centro Hospitalar do Porto- Hospital de Santo António

Porto, 4099-001, Portugal

Location

Centro Hospitalar de São João, EPE - Serviço de Oftalmologia

Porto, 4200-319, Portugal

Location

Bellvitge University Hospital

Barcelona, Spain

Location

Instituto de Microcirugia Ocular

Barcelona, Spain

Location

Vall d'Hebron Hospital

Barcelona, Spain

Location

Hospital Insular de Gran Canaria

Las Palmas, Spain

Location

Related Publications (2)

  • 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.

    PMID: 34348351DERIVED

  • 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.

    PMID: 28851779DERIVED

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Condition Hierarchy (Ancestors)

Choroidal NeovascularizationChoroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rufino Silva, PhD

    Association for Innovation and Biomedical Research on Light and Image

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

July 13, 2015

Study Start

November 23, 2015

Primary Completion

August 22, 2017

Study Completion

December 17, 2019

Last Updated

January 10, 2020

Record last verified: 2019-02

Locations

ES(4)PT(9)