Skip to main content
OpenTrials
Completed

NCT Number: NCT02495181

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polypoidal Choroidal Vasculopathy Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Braga, Braga, Portugal

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravitreal Aflibercept

Drug

Other names: standard photodynamic therapy (PDT)

Primary outcomes

  1. Change in Best Corrected Visual Acuity (BCVA)

    Time frame: from Baseline (Week 0) to Week 52.

    Unit of Measure: [Letters]

  2. Polyps regression

    Time frame: from Baseline (W0) to Week 52.

    Unit of Measure: [Yes, No]

Secondary outcomes

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

    Time frame: from Baseline (W0) to Week 16

    Unit of Measure: [Yes, No]

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

    Time frame: from Baseline (W0) to Week 52

    Unit of Measure: [Yes, No]

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

    Time frame: from Baseline (W0) to Week 52

    Unit of Measure: [Yes, No]

  4. 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]

  5. 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]

  6. Total number of treatments with Aflibercept;

    Time frame: from Baseline (W0) to Week 52

    Unit of Measure: [#]

  7. 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]

Sponsors and collaborators

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image

Other

Collaborators

  • European Vision Institute Clinical Research Network

Registry information

Official study 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.

Acronym: ATLANTIC

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Jul 13, 2015
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.