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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)

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ClinicalTrials.gov Identifier: NCT02495181
Recruitment Status : Completed
First Posted : July 13, 2015
Last Update Posted : January 10, 2020
Sponsor:
Collaborator:
European Vision Institute Clinical Research Network
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image

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).

Condition or disease Intervention/treatment Phase
Polypoidal Choroidal Vasculopathy Drug: Intravitreal Aflibercept Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : November 23, 2015
Actual Primary Completion Date : August 22, 2017
Actual Study Completion Date : December 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Aflibercept Monotherapy
IVT Aflibercept 2 mg + Sham PDT
Drug: Intravitreal Aflibercept
Other Name: standard photodynamic therapy (PDT)

Active Comparator: Aflibercept + verteporfin PDT
IVT Aflibercept 2 mg + Verteporfin PDT
Drug: Intravitreal Aflibercept
Other Name: standard photodynamic therapy (PDT)




Primary Outcome Measures :
  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 Outcome Measures :
  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]



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495181


Locations
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Portugal
Hospital de Braga
Braga, Portugal, 4710-243
AIBILI - Centro de Ensaios Clínicos
Coimbra, Portugal, 3000-548 Coimbra
Espaço Médico de Coimbra
Coimbra, Portugal, 3030-163
Centro Hospitalar de Leiria
Leiria, Portugal, 2400-171
IRL - Instituto de Retina e Diabetes de Lisboa
Lisboa, Portugal, 1050-085 Lisboa
Centro Hospitgalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisboa, Portugal, 1649-035
Instituto de Oftalmologia Dr. Gama Pinto
Lisboa, Portugal
Centro Hospitalar do Porto- Hospital de Santo António
Porto, Portugal, 4099-001
Centro Hospitalar de São João, EPE - Serviço de Oftalmologia
Porto, Portugal, 4200-319
Spain
Bellvitge University Hospital
Barcelona, Spain
Instituto de Microcirugia Ocular
Barcelona, Spain
Vall d'Hebron Hospital
Barcelona, Spain
Hospital Insular de Gran Canaria
Las Palmas, Spain
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
European Vision Institute Clinical Research Network
Investigators
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Principal Investigator: Rufino Silva, PhD Association for Innovation and Biomedical Research on Light and Image
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT02495181    
Other Study ID Numbers: ECR-AMD-2015-09
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: February 2019
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents