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

Polypoidal Choroidal Vasculopathy Clinical Trial

— PCV  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381730
• Other study ID #: 2013-A01717-38
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: December 7, 2017
• Start date: January 2014
• Est. completion date: August 31, 2017

Study information

• Verified date: December 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
France	CHU Lyon Croix Rousse	Lyon
France	Fondation Ophtalmologique A. de Rothschild	Paris
France	Centre Médical de la Rétine Maison Rouge	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection		28 weeks