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)

January 8, 2020 updated by: Association for Innovation and Biomedical Research on Light and Image

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Coimbra, Portugal, 3030-163
        • Espaço Médico de Coimbra
      • Coimbra, Portugal, 3000-548 Coimbra
        • AIBILI - Centro de Ensaios Clínicos
      • Leiria, Portugal, 2400-171
        • Centro Hospitalar de Leiria
      • Lisboa, Portugal, 1050-085 Lisboa
        • IRL - Instituto de Retina e Diabetes de Lisboa
      • Lisboa, Portugal, 1649-035
        • Centro Hospitgalar de Lisboa Norte, EPE - Hospital de Santa Maria
      • Lisboa, Portugal
        • Instituto de Oftalmologia Dr. Gama Pinto
      • Porto, Portugal, 4099-001
        • Centro Hospitalar do Porto- Hospital de Santo Antonio
      • Porto, Portugal, 4200-319
        • Centro Hospitalar de São João, EPE - Serviço de Oftalmologia
  • Spain
      • Barcelona, Spain
        • Vall d'Hebron Hospital
      • Barcelona, Spain
        • Bellvitge University Hospital
      • Barcelona, Spain
        • Instituto de Microcirugia Ocular
      • Las Palmas, Spain
        • Hospital Insular de Gran Canaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Aflibercept Monotherapy
IVT Aflibercept 2 mg + Sham PDT
Drug: Intravitreal Aflibercept
Other Names:
  • standard photodynamic therapy (PDT)
Active Comparator: Aflibercept + verteporfin PDT
IVT Aflibercept 2 mg + Verteporfin PDT
Drug: Intravitreal Aflibercept
Other Names:
  • standard photodynamic therapy (PDT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Best Corrected Visual Acuity (BCVA)
Time Frame: from Baseline (Week 0) to Week 52.
Unit of Measure: [Letters]
from Baseline (Week 0) to Week 52.
Polyps regression
Time Frame: from Baseline (W0) to Week 52.
Unit of Measure: [Yes, No]
from Baseline (W0) to Week 52.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyps regression, assessed by Indocyanine Green Angiography (ICGA);
Time Frame: from Baseline (W0) to Week 16
Unit of Measure: [Yes, No]
from Baseline (W0) to Week 16
Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA);
Time Frame: from Baseline (W0) to Week 52
Unit of Measure: [Yes, No]
from Baseline (W0) to Week 52
Presence of leakage based on fluorescein angiography (FA)
Time Frame: from Baseline (W0) to Week 52
Unit of Measure: [Yes, No]
from Baseline (W0) to Week 52
Change in the Subfield Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT);
Time Frame: from Baseline (W0) to Week 52
Unit of Measure: [µm]
from Baseline (W0) to Week 52
Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52;
Time Frame: from Baseline (W0) to Week 52
Unit of Measure: [Yes, No]
from Baseline (W0) to Week 52
Total number of treatments with Aflibercept;
Time Frame: from Baseline (W0) to Week 52
Unit of Measure: [#]
from Baseline (W0) to Week 52
Frequency and severity of ocular and non-ocular adverse events over time.
Time Frame: from Baseline (W0) to Week 52
Unit of Measure: [Mild, Moderate, Severe]
from Baseline (W0) to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Collaborators

European Vision Institute Clinical Research Network

Investigators

  • Principal Investigator: Rufino Silva, PhD, Association for Innovation and Biomedical Research on Light and Image

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2015

Primary Completion (Actual)

August 22, 2017

Study Completion (Actual)

December 17, 2019

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimate)

July 13, 2015

Study Record Updates

Last Update Posted (Actual)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECR-AMD-2015-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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