Overview

This trial is active, not recruiting.

Condition polypoidal choroidal vasculopathy
Treatment intravitreal aflibercept
Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Start date January 2014
End date December 2016
Trial size 37 participants
Trial identifier NCT02381730, 2013-A01717-38

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
intravitreal aflibercept
Patient receive one intravitreal injection of 2mg aflibercept (as currently recommended in the treatment of AMD)

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 45 years old.

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

Additional Information

Principal investigator Martine Mauget-Faysse
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Fondation Ophtalmologique Adolphe de Rothschild.