Real Life Study in Myopic Neovascularization

Myopic Choroidal Neovascularisation Clinical Trial

— VIC  

Official title:

Real Life Study in Myopic Neovascularization

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03797547
• Other study ID #: VIC
• Status: Active, not recruiting
• Start date: June 22, 2018
• Est. completion date: January 30, 2023

Study information

• Verified date: September 2021
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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 who did not receive injection since the last 3 month
• 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

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Myopia
• Myopic Choroidal Neovascularisation
• Neovascularization, Pathologic

Intervention

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

Locations

Country	Name	City	State
France	Chu de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	visual acuity measurement in naive patient	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	12, 24 and 36 months
Secondary	visual acuity measurement after other treatment such as laser, pdt visudyneor other IVT treatment	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	6, 12, 24 and 36 months
Secondary	pourcentage of patients who gain more than or equal of 15 letters	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,	6,12,24 and 36 months
Secondary	Anatomics parameters by oct	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	6, 12, 24 and 36 months
Secondary	Anatomics parameters by color photographs	On color retinal photographs: Presence of retinal hemorrhage Presence of macular atrophy or lacquer cracks,	6, 12, 24 and 36 months
Secondary	Anatomic parameters by fluoresceine angiography or angiography oct	On fluoresceine angiography if deemed necessary by the investigator : diffusion during late phases On angiography OCT : neovascular network visualisation	6, 12, 24 and 36 months