NCT02387957

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Ophthotech Corporation · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Fovista®
DRUG	bevacizumab
DRUG	ranibizumab
DRUG	aflibercept

Timeline

• Start date: 2016-04-26
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-03-13
• Last updated: 2024-10-30
• Results posted: 2019-03-05

Locations

24 sites across 1 country: United States