Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-03 @ 7:36 PM
Study NCT ID:
NCT03393767
Status:
COMPLETED
Last Update Posted:
2018-01-08
First Post:
2014-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time Course of Activity Signs at SD-OCT High Frequency Intravitreal Ranibizumab Treatment in CNV Due to AMD
Sponsor:
Vista Klinik
Organization:
Study Overview
Official Title:
Time Course of Activity Signs at High Resolution OCT During OCT-guided High Frequency Intravitreal Ranibizumab Treatment in Choroidal Neovascularization Due to Age Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
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:
None
Brief Summary:
The purpose of the study is to detect persisting or early new activity of choroidal neovascularization (CNV) due to age related macular degeneration (AMD) during the first 12 months following the first ranibizumab dose at baseline as assessed by weekly high resolution optical coherence tomography (OCT). Detection of persisting or new signs of CNV activity at OCT triggers further ranibizumab treatments considering that any ranibizumab injections can maximally be applied as often as 2-weekly.
Detailed Description:
This is a prospective, 1-arm, monocenter study designed to evaluate the time course of early re-activation of CNV assessed by High Resolution OCT. An OCT-guided high frequency (up to 2-weekly) intravitreal ranibizumab treatment in CNV due to AMD may prevent further growth and early re-growth of CNV as evaluated by OCT at a weekly basis.
Consenting, enrolled patients will receive one 0.5 mg ranibizumab intravitreal injection at baseline (month 0). Afterwards all patients will undergo a weekly OCT assessment. Further treatments, which can maximally be applied as often as 2-weekly, are triggered by persisting or new signs of CNV activity at OCT as defined by intraretinal cysts or subretinal fluid. For this study, a month is defined as 28 days, a 2-week period as 14 days. During the 12-month study period, a maximum of 24 ranibizumab injections may be administered.
An interim analysis will not be performed. The study will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).
Consenting, enrolled patients will receive one 0.5 mg ranibizumab intravitreal injection at baseline (month 0). Afterwards all patients will undergo a weekly OCT assessment. Further treatments, which can maximally be applied as often as 2-weekly, are triggered by persisting or new signs of CNV activity at OCT as defined by intraretinal cysts or subretinal fluid. For this study, a month is defined as 28 days, a 2-week period as 14 days. During the 12-month study period, a maximum of 24 ranibizumab injections may be administered.
An interim analysis will not be performed. The study will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).
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?: