Real Life Study in Myopic Neovascularization

NCT03797547 | Unknown

• 1 other identifier: VIC
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopic Choroidal Neovascularisation

Outcome Measures

Primary Outcomes (1)

• visual acuity measurement

  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

  6, 12, 24 and 36 months

Secondary Outcomes (6)

• visual acuity measurement in naive patient

  12, 24 and 36 months

• visual acuity measurement after other treatment such as laser, pdt visudyneor other IVT treatment

  6, 12, 24 and 36 months

• pourcentage of patients who gain more than or equal of 15 letters

  6,12,24 and 36 months

• Anatomics parameters by oct

  6, 12, 24 and 36 months

• Anatomics parameters by color photographs

  6, 12, 24 and 36 months

Interventions

AFLIBERCEPT OTHER

Patients will be treated following a real life protocol and according to the French recommendation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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, who did not receive injection since the last 3 month

You may qualify if:

• 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 who did not receive injection since the last 3 month
• with OCT or angiography examination

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Chu de Poitiers

Poitiers, France

Location

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: January 9, 2019
• Study Start: June 22, 2018
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

FR (1)