Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 7:34 AM
Study NCT ID:
NCT04922151
Status:
UNKNOWN
Last Update Posted:
2021-06-10
First Post:
2021-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)
Sponsor:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double Masked, Multicenter, Phase II Study Assessing the Safety and Efficacy of 601 Versus Ranibizumab in Patients With Visual Impairment Due to Pathological Myopic Choroidal Neovascularization (pmCNV)
Status:
UNKNOWN
Status Verified Date:
2021-06
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:
None
Brief Summary:
To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to pmCNV
Detailed Description:
Following a 14-day maximum screening period, patients will be randomized and followed for approximately 36 weeks. Treatment visits will be scheduled in 4-week intervals. After 1 initial injection of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 4 to week 32). During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an injection or not. Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: