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Real Life Study in Myopic Neovascularization (VIC)

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ClinicalTrials.gov Identifier: NCT03797547
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:

This is a multi centre, single arm, prospective observational phase 4 study in naive or pretreated patients with myopic neovascularization. The patients will be treated with intravitreal injections of Aflibercept following a real life protocol.

This sudy aims to evaluate the visual acuity during a 36 months period of time.


Condition or disease Intervention/treatment
Myopic Choroidal Neovascularisation Other: AFLIBERCEPT

Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Life Study in Myopic Neovascularization
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : June 22, 2019
Estimated Study Completion Date : June 22, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept


Intervention Details:
  • Other: AFLIBERCEPT
    Patients will be treated following a real life protocol and according to the French recommendation


Primary Outcome Measures :
  1. visual acuity measurement [ Time Frame: 6, 12, 24 and 36 months ]
    Efficacy measurement will be performed by mean change of "ETDRS" for Best Corrected Visual Acuity evaluation (ETDRS score at 4 meters) from baseline to 6, 12, 24 and 36 month after initation of treatment by aflibercept


Secondary Outcome Measures :
  1. visual acuity measurement in naive patient [ Time Frame: 12, 24 and 36 months ]
    Efficacy measurement will be performed by mean change of "ETDRS" for Best corrected visual acuity evaluation from baseline to month 12, 24 and 36 after initation of treatment by aflibercept in naïve patients

  2. visual acuity measurement after other treatment such as laser, pdt visudyneor other IVT treatment [ Time Frame: 6, 12, 24 and 36 months ]
    Efficacy measurement will be evaluated by mean change of "ETDRS" for Best corrected visual Acuity evaluation after initation of treatment by aflibercept after switch from other treatment such as laser, visudyne PDT or other IVT treatment, after 6, 12, 24 and 36 months of treatment with Eylea

  3. pourcentage of patients who gain more than or equal of 15 letters [ Time Frame: 6,12,24 and 36 months ]
    Efficacy measurement will be evaluated by pourcentage of patients who gain more than or equal of 15 letters at 6, 12, 24 and 36 months after initiation of treatment with aflibercept within naïve or after switch from other treatment such as laser, visudyne PDT or other IVT treatment,

  4. Anatomics parameters by oct [ Time Frame: 6, 12, 24 and 36 months ]

    Evaluation of anatomic parameters will be perfomed after 6,12, and 24 and 36 months of treatment with Eylea based on OCT parameters :

    On SD-OCT :

    Distance from CNV lesion to the fovea measured on the scan joining the fovea to the foveal edge of the mCNV Exudation assessed by presence of intraretinal cysts or subretinal fluid Central retinal thickness


  5. Anatomics parameters by color photographs [ Time Frame: 6, 12, 24 and 36 months ]

    On color retinal photographs:

    Presence of retinal hemorrhage Presence of macular atrophy or lacquer cracks,


  6. Anatomic parameters by fluoresceine angiography or angiography oct [ Time Frame: 6, 12, 24 and 36 months ]
    On fluoresceine angiography if deemed necessary by the investigator : diffusion during late phases On angiography OCT : neovascular network visualisation



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Active mCNV among:
  • Naïve patients.
  • Patients with previous history of laser photocoagulation or PDT, with no history of anti-VEGF.
  • Patients with previous history of other anti-VEGF treatments.including ranibizumab or bevacizumab, with sustaining mCNV activity despite 3 or more intravitreal injections withing the last 6 months.
Criteria

Inclusion Criteria:

  • Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potenteial (hormonal or any intrauterine devices).
  • High myopy defined by refractive error ≤ -6 D or History of high myopia among pseudophakic patient or patient treated with refractive surgery
  • Patient with active CNVm
  • Patients naïve or Patients pretreated with previous history of laser photocoagulation or PDT or by other anti-VEGF treatments with sustaining mCNV activity despite 3 or more intravitreal injections withing the last 6 months.

    • with OCT or angiography examination

Exclusion Criteria:

  • Treatment with an anti VEGF administrated by intravitreal injection within 1 months prior to baseline in the study eye.
  • Treatment with PDT or laser administrated within 6 months prior to baseline in the study eye.
  • History of vitrectomy in the study eye
  • History of any other retinal disease
  • VA less than 20/250

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): NCT03797547


Contacts
Contact: NICOLAS LEVEZIEL +33549444182 nicolas.leveziel@chu-poitiers.fr

Locations
France
Chu de Poitiers Recruiting
Poitiers, France
Contact: NICOLAS LEVEZIEL, PUPH         
Sponsors and Collaborators
Poitiers University Hospital

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03797547     History of Changes
Other Study ID Numbers: VIC
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Myopia
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Refractive Errors