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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 (ATLANTIC)

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Intravitreal Aflibercept
Sponsored by
Association for Innovation and Biomedical Research on Light and Image
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital de Braga
  • AIBILI - Centro de Ensaios Clínicos
  • Espaço Médico de Coimbra
  • Centro Hospitalar de Leiria
  • IRL - Instituto de Retina e Diabetes de Lisboa
  • Centro Hospitgalar de Lisboa Norte, EPE - Hospital de Santa Maria
  • Instituto de Oftalmologia Dr. Gama Pinto
  • Centro Hospitalar do Porto- Hospital de Santo António
  • Centro Hospitalar de São João, EPE - Serviço de Oftalmologia
  • Bellvitge University Hospital
  • Instituto de Microcirugia Ocular
  • Vall d'Hebron Hospital
  • Hospital Insular de Gran Canaria

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Aflibercept Monotherapy

Aflibercept + verteporfin PDT

Arm Description

IVT Aflibercept 2 mg + Sham PDT

IVT Aflibercept 2 mg + Verteporfin PDT

Outcomes

Primary Outcome Measures

Change in Best Corrected Visual Acuity (BCVA)
Unit of Measure: [Letters]
Polyps regression
Unit of Measure: [Yes, No]

Secondary Outcome Measures

Polyps regression, assessed by Indocyanine Green Angiography (ICGA);
Unit of Measure: [Yes, No]
Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA);
Unit of Measure: [Yes, No]
Presence of leakage based on fluorescein angiography (FA)
Unit of Measure: [Yes, No]
Change in the Subfield Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT);
Unit of Measure: [µm]
Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52;
Unit of Measure: [Yes, No]
Total number of treatments with Aflibercept;
Unit of Measure: [#]
Frequency and severity of ocular and non-ocular adverse events over time.
Unit of Measure: [Mild, Moderate, Severe]

Full Information

First Posted
March 23, 2015
Last Updated
January 8, 2020
Sponsor
Association for Innovation and Biomedical Research on Light and Image
Collaborators
European Vision Institute Clinical Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT02495181
Brief Title
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
Acronym
ATLANTIC
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 23, 2015 (Actual)
Primary Completion Date
August 22, 2017 (Actual)
Study Completion Date
December 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association for Innovation and Biomedical Research on Light and Image
Collaborators
European Vision Institute Clinical Research Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypoidal Choroidal Vasculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept Monotherapy
Arm Type
Sham Comparator
Arm Description
IVT Aflibercept 2 mg + Sham PDT
Arm Title
Aflibercept + verteporfin PDT
Arm Type
Active Comparator
Arm Description
IVT Aflibercept 2 mg + Verteporfin PDT
Intervention Type
Drug
Intervention Name(s)
Intravitreal Aflibercept
Other Intervention Name(s)
standard photodynamic therapy (PDT)
Primary Outcome Measure Information:
Title
Change in Best Corrected Visual Acuity (BCVA)
Description
Unit of Measure: [Letters]
Time Frame
from Baseline (Week 0) to Week 52.
Title
Polyps regression
Description
Unit of Measure: [Yes, No]
Time Frame
from Baseline (W0) to Week 52.
Secondary Outcome Measure Information:
Title
Polyps regression, assessed by Indocyanine Green Angiography (ICGA);
Description
Unit of Measure: [Yes, No]
Time Frame
from Baseline (W0) to Week 16
Title
Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA);
Description
Unit of Measure: [Yes, No]
Time Frame
from Baseline (W0) to Week 52
Title
Presence of leakage based on fluorescein angiography (FA)
Description
Unit of Measure: [Yes, No]
Time Frame
from Baseline (W0) to Week 52
Title
Change in the Subfield Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT);
Description
Unit of Measure: [µm]
Time Frame
from Baseline (W0) to Week 52
Title
Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52;
Description
Unit of Measure: [Yes, No]
Time Frame
from Baseline (W0) to Week 52
Title
Total number of treatments with Aflibercept;
Description
Unit of Measure: [#]
Time Frame
from Baseline (W0) to Week 52
Title
Frequency and severity of ocular and non-ocular adverse events over time.
Description
Unit of Measure: [Mild, Moderate, Severe]
Time Frame
from Baseline (W0) to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rufino Silva, PhD
Organizational Affiliation
Association for Innovation and Biomedical Research on Light and Image
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
AIBILI - Centro de Ensaios Clínicos
City
Coimbra
ZIP/Postal Code
3000-548 Coimbra
Country
Portugal
Facility Name
Espaço Médico de Coimbra
City
Coimbra
ZIP/Postal Code
3030-163
Country
Portugal
Facility Name
Centro Hospitalar de Leiria
City
Leiria
ZIP/Postal Code
2400-171
Country
Portugal
Facility Name
IRL - Instituto de Retina e Diabetes de Lisboa
City
Lisboa
ZIP/Postal Code
1050-085 Lisboa
Country
Portugal
Facility Name
Centro Hospitgalar de Lisboa Norte, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Instituto de Oftalmologia Dr. Gama Pinto
City
Lisboa
Country
Portugal
Facility Name
Centro Hospitalar do Porto- Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Centro Hospitalar de São João, EPE - Serviço de Oftalmologia
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Bellvitge University Hospital
City
Barcelona
Country
Spain
Facility Name
Instituto de Microcirugia Ocular
City
Barcelona
Country
Spain
Facility Name
Vall d'Hebron Hospital
City
Barcelona
Country
Spain
Facility Name
Hospital Insular de Gran Canaria
City
Las Palmas
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
34348351
Citation
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.
Results Reference
derived
PubMed Identifier
28851779
Citation
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.
Results Reference
derived

Learn more about this trial

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

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