Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-28 @ 11:52 AM
Study NCT ID:
NCT02092532
Status:
UNKNOWN
Last Update Posted:
2014-10-15
First Post:
2014-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Aflibercept for Neovascular Polypoidal Choroidal Vasculopathy (RIVAL Trial)
Sponsor:
Southeast Retina Center, Georgia
Organization:
Study Overview
Official Title:
Open-label, Non-randomized, Unmasked, Study of IAI in Patients Which Choroidal Neovascularization Secondary to Polypoidal Choroidal Vasculopathy (PCV)
Status:
UNKNOWN
Status Verified Date:
2014-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIVAL
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.
Detailed Description:
This is an open-label, non-randomized, unmasked, study of IAI in patients with choroidal neovascularization secondary to polypoidal choroidal vasculopathy (PCV). Twenty treatment naïve and previously treated PCV eyes will be enrolled (only one study eye per patient will be enrolled). A maximum of 10 previously treated eyes will be enrolled. Consented, enrolled patients will be followed monthly. All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months. Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met. Starting at Month 3, patients can receive non-anti vascular endothelial growth factor (VEGF) rescue therapy (ie: Photodynamic Therapy (PDT), laser, intravitreal steroids) if the pre-defined criteria are met.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: