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

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).

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Key information

Conditions

Polypoidal Choroidal Vasculopathy Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Lyon Croix Rousse, Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravitreal Aflibercept

Drug

Patient receive one intravitreal injection of 2mg aflibercept (as currently recommended in the treatment of AMD)

Primary outcomes

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

Time frame: 28 weeks

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: PCV

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Mar 6, 2015
Registry last updated: Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed