Assessment of Visual Acuity in Patients With Polypoidal Choroidal Vasculopathy and Aflibercept Treatment (PCV)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Polypoidal Choroidal Vasculopathy

Treatments: Drug: Intravitreal aflibercept

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02381730

2013-A01717-38

Details and patient eligibility

About

Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response to anti-vascular agents differs from the response of typical AMD.

This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).

Enrollment: 37 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active polypoidal choroidal vasculopathy,
• Visual acuity superior to 1/10 (20/200) and inferior to 6,25/10 (20/32)
• Age above 45
• No prior intravitreal treatment, or no response to prior treatment by 3 injections of ranibizumab, or disease recurrence after more than 3 months of stability
• Intravitreal injection of aflibercept is indicated by current clinical recommendations

Exclusion criteria

• Simultaneous treatment with another anti-VEGM agent
• Diabetic retinopathy
• Personal history of vitrectomy or uveitis
• Personal history laser photocoagulation and/or verteporphin phototherapy
• Tear in the pigmentary epithelium
• Chorioretinitis scar
• Macular atrophy in the pigmentary epithelium
• Treatment with corticosteroids
• Eye surgery less than 3 months before inclusion

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Aflibercept

Experimental group

Treatment:

Drug: Intravitreal aflibercept