Assessment of Visual Acuity in Patients With Polypoidal Choroidal Vasculopathy and Aflibercept Treatment
PCV
1 other identifier
interventional
37
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedDecember 8, 2017
December 1, 2017
3.7 years
March 5, 2015
December 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection
28 weeks
Study Arms (1)
Aflibercept
EXPERIMENTALInterventions
Patient receive one intravitreal injection of 2mg aflibercept (as currently recommended in the treatment of AMD)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
CHU Lyon Croix Rousse
Lyon, France
Fondation Ophtalmologique A. de Rothschild
Paris, 75019, France
Centre Médical de la Rétine Maison Rouge
Strasbourg, 67000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martine Mauget-Faysse
Fondation Ophtalmologique A. de Rothschild
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2015
First Posted
March 6, 2015
Study Start
January 1, 2014
Primary Completion
August 31, 2017
Study Completion
August 31, 2017
Last Updated
December 8, 2017
Record last verified: 2017-12