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

Not Applicable

Completed

• Conditions: Polypoidal Choroidal Vasculopathy
• Interventions: Drug: Intravitreal aflibercept

• Registration Number: NCT02381730
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-06
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aflibercept	Intravitreal aflibercept	-

Primary Outcome Measures

Name	Time	Method
Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection	28 weeks

Trial Locations

Locations (3)

Fondation Ophtalmologique A. de Rothschild; 🇫🇷 Paris, France

CHU Lyon Croix Rousse; 🇫🇷 Lyon, France

Centre Médical de la Rétine Maison Rouge; 🇫🇷 Strasbourg, France