Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD

Age-related Macular Degeneration Clinical Trial

Official title:

A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the Induction and Maintenance Phase of Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02214628
• Other study ID #: OPH1005
• Status: Terminated
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.

Description:

The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Subjects of either gender aged = 50 years

• All fluorescein angiographic subtypes with presence of active choroidal neovascularization

Exclusion Criteria:

• Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication

• Subjects with subfoveal scar or subfoveal atrophy

• Any ocular or periocular infection in the past twelve (12) weeks

• History of any of the following conditions or procedures in the study eye:

Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Fovista® (anti-PDGF BB) plus anti-VEGF

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ophthotech Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)	Number of subjects on either arm with non-serious adverse events (reported by >5% of subjects)	2 years
Primary	Number of Subjects With Serious Adverse Events	Number of subjects with serious adverse events in each arm	2 years