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Choroidal NeovascularizationNCT04075188

Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

A study testing Aflibercept Injection in people with Choroidal Neovascularization and Choroid Disease, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate patients with diagnosis of polypoidal choroidal vasculopathy (PCV) in pachychoroid treated with combined therapy, consisting in photodynamic therapy (PDT) and 3 intravitreal therapy (IVT) of Aflibercept monthly. This is a single center, prospective case-series study. Read more about this study

Who is it for?
Any age
Conditions the study is for
Choroidal Neovascularization, Choroid Disease
What is being tested?
Aflibercept Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteItaly
Study dates
18 Sep 2017to 13 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • presence of haemorrhagic or exudative PCV diagnosed by OCT and ICGA
  • Mean central choroidal thickness > 250 µm

Who cannot join

  • ocular comorbidity
  • previous cardiovascular events
  • different ocular surgical procedures form cataract surgery

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

Other trials in Italy

About this study

Official title: Polypoidal Choroidal Vasculopathy in Pachychoroid: Aflibercept + PDT Combined Therapy

This study will evaluate patients with diagnosis of polypoidal choroidal vasculopathy (PCV) in pachychoroid treated with combined therapy, consisting in photodynamic therapy (PDT) and 3 intravitreal therapy (IVT) of Aflibercept monthly. This is a single center, prospective case-series study. The investigators are going to evaluate Corrected Distance Visual Acuity (CDVA), disease activity, retinal and choroidal thicknesses and number of injection per year, during a twelve month follow up. The aim of this study is to verify if the combined therapy can act on the insult induced by the pachychoroid and on the neovascular lesion itself in this sub-population of patients with PCV in pachychoroid,

Read the detailed description

This study evaluates patients with diagnosis of polypoidal choroidal vasculopathy (PCV) in pachychoroid treated with combined therapy, consisting in photodynamic therapy (PDT) and 3 intravitreal therapy (IVT) of Aflibercept monthly. Inclusion criteria are the presence of haemorrhagic or exudative PCV diagnosed by Optical Coherence Tomography (OCT) and Indocyanine Green Angiography (ICGA) and the mean central choroidal thickness > 250 µm. Exclusion criteria comprehend ocular comorbidity, previous cardiovascular events and different ocular surgical procedures form cataract surgery. Participants undergo a thorough ophthalmic assessment that included best corrected visual acuity (CDVA), slit lamp biomicroscopy and dilated funduscopic examination. OCT, OCT-Angiography (OCT-A), ICGA and Fluoresceine Angiography (FA) were performed for all patients. The 12-month follow-up foresee monthly revaluations of the above measurements, excluding FA, repeated only on clinical judgement. CDVA will be measured using LogMAR. Choroidal and retinal thicknesses will be automatically measured by digital software OCT- integrated (IMAGEnet). All patients will be treated with a loading dose of Aflibercept combined with PDT within the first 7 days of the first intravitreal therapy. The spot size is calculated by adding 1000 μm to the greater linear dimension of the lesion. No additional therapy will be performed during follow-up unless signs of reactivation.

Being tested
Aflibercept Injection
Keywords
pachychoroid, polypoidal choroidal vasculopathy, Aflibercept, photodynamic therapy, Swept source OCT
Medical subject headings
Choroidal Neovascularization, Choroid Diseases, Polypoidal Choroidal Vasculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aflibercept InjectionDrug

    Also called verteporfin for injection

    Patients will be treated with combined therapy to determine the synergy of this treatment, causing anti- Vascular Endothelial Growth Factor (anti-VEGF) to block neovascular exudation and photodynamic therapy to close aneurismal vessel and reduce choroidal vascular congestion.

Study groups in NCT04075188
Study groupRoleWhat they receive
Combined therapyExperimentalTreatment consisting in photodynamic therapy (Verteporfin, 6 mg/m2 × Body Surface Area (BSA) = Total Drug Dose; Total Drug Dose ÷ 2.0 mg/mL = Volume of Reconstituted Verteporfin; 30 mL - Volume of Reconstituted Verteporfin = Volume of 5% dextrose in water. Light dose is 50 J/cm2 administered at an intensity of 600 mW/cm2. This dose is administered over 83 seconds) and 3 intravitreal therapy of Aflibercept (2 mg/0,05 ml)monthly, the first of which performed within 7 days from photodynamic therapy.
Receives: Drug: Aflibercept Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Corrected Distance Visual Acuity

    measured in logMAR notation using Early Treatment of Diabetic Retinopathy Study charts (CC-100XP LCD System for ETDRS Chart display)

    Measured: twelve months

  2. Disease Activity

    measured as percentage of patients with subretinal or intraretinal fluid

    Measured: twelve months

  3. Retinal Thickness

    Central retinal thickness (1 mm central foveal thickness) and mean macular thickness (second and the third 6-mm grid including parafoveal and perifoveal macular area)

    Measured: twelve months

  4. Choroidal thickness

    Central choroidal thickness (1 mm central subfoveal thickness) and mean choroideal thickness (second and the third 6-mm grid including parafoveal and perifoveal choroidal area)

    Measured: twelve months

Secondary outcomes (1)

  1. Number of injections per year

    Number of intravitreal injection administered in a year

    Measured: twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2019
  2. Study start18 Sep 2017
  3. Primary completion1 Jun 2018
  4. Study completion13 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Selected patients with both diagnosis of polypoidal choroidal vasculoparthy and pachychoroid will be treated with combined therapy consisting in photodynamic therapy and 3 intravitreal therapy of Aflibercept monthly
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04075188
Sponsor's protocol ID
PDT Aflibercept
Status last verified
Aug 2019
First submitted
29 Aug 2019
Last updated
3 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yuzawa M, Mori R, Kawamura A. The origins of polypoidal choroidal vasculopathy. Br J Ophthalmol. 2005 May;89(5):602-7. doi: 10.1136/bjo.2004.049296.

    PubMed 15834093

  • Koh A, Lai TYY, Takahashi K, Wong TY, Chen LJ, Ruamviboonsuk P, Tan CS, Feller C, Margaron P, Lim TH, Lee WK; EVEREST II study group. Efficacy and Safety of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Nov 1;135(11):1206-1213. doi: 10.1001/jamaophthalmol.2017.4030.

    PubMed 28983556

  • Wong TY, Ogura Y, Lee WK, Iida T, Chen SJ, Mitchell P, Gemmy Cheung CM, Zhang Z, Leal S, Ishibashi T; PLANET Investigators. Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy: Two-Year Results of the Aflibercept in Polypoidal Choroidal Vasculopathy Study. Am J Ophthalmol. 2019 Aug;204:80-89. doi: 10.1016/j.ajo.2019.02.027. Epub 2019 Mar 6.

    PubMed 30849345

  • Pang CE, Freund KB. Pachychoroid neovasculopathy. Retina. 2015 Jan;35(1):1-9. doi: 10.1097/IAE.0000000000000331.

    PubMed 25158945

  • Balaratnasingam C, Lee WK, Koizumi H, Dansingani K, Inoue M, Freund KB. Polypoidal Choroidal Vasculopathy: A Distinct Disease or Manifestation of Many? Retina. 2016 Jan;36(1):1-8. doi: 10.1097/IAE.0000000000000774. No abstract available.

    PubMed 26414957

  • Yanagi Y, Ting DSW, Ng WY, Lee SY, Mathur R, Chan CM, Yeo I, Wong TY, Cheung GCM. CHOROIDAL VASCULAR HYPERPERMEABILITY AS A PREDICTOR OF TREATMENT RESPONSE FOR POLYPOIDAL CHOROIDAL VASCULOPATHY. Retina. 2018 Aug;38(8):1509-1517. doi: 10.1097/IAE.0000000000001758.

    PubMed 28704255

Questions about this trial

What is this clinical trial studying?

A study testing Aflibercept Injection in people with Choroidal Neovascularization and Choroid Disease, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Corrected Distance Visual Acuity (time frame: twelve months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04075188, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.

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