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)

Age-Related Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02387957
• Other study ID #: OPH1006
• Status: Terminated
• Phase: Phase 2
• Start date: April 26, 2016
• Est. completion date: January 2017

Study information

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

Clinical Trial Summary

To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Subjects of either gender aged = 50 years.

• Active subfoveal choroidal neovascularization (CNV) due to AMD.

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®

• bevacizumab

• ranibizumab

• aflibercept

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	Total Numer of Systemic Adverse Events	Number of Patients with Systemic Adverse Events	2 years
Primary	Total Number of Other Adverse Events (>5%)	Number of Patients with Other Adverse Events	2 years