Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-23 @ 7:57 AM
Study NCT ID:
NCT02387957
Status:
TERMINATED
Last Update Posted:
2024-10-30
First Post:
2015-03-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)
Sponsor:
Ophthotech Corporation
Organization:
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2019-02
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:
To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.
Detailed Description:
60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows:
* Avastin® 1.25 mg/eye (20 subjects)
* Lucentis® 0.5 mg/eye (20 subjects)
* Eylea® 2.0 mg/eye (20 subjects)
Subjects will be stratified by lesion size (≤2 DA vs. \>2 DA).
Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.
When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).
* Avastin® 1.25 mg/eye (20 subjects)
* Lucentis® 0.5 mg/eye (20 subjects)
* Eylea® 2.0 mg/eye (20 subjects)
Subjects will be stratified by lesion size (≤2 DA vs. \>2 DA).
Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.
When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).
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?: