Back to resultsA 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)
Primary Purpose
Age-Related Macular Degeneration
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fovista®
bevacizumab
ranibizumab
aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Wet AMD, subfoveal choroidal neovascularization, Fovista®, Avastin®, Lucentis®, Eylea®
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Fovista® plus bevacizumab
Fovista® plus ranibizumab
Fovista® plus aflibercept
Arm Description
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Outcomes
Primary Outcome Measures
Total Numer of Systemic Adverse Events
Number of Patients with Systemic Adverse Events
Total Number of Other Adverse Events (>5%)
Number of Patients with Other Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02387957
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Study Start Date
April 26, 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophthotech Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Wet AMD, subfoveal choroidal neovascularization, Fovista®, Avastin®, Lucentis®, Eylea®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fovista® plus bevacizumab
Arm Type
Experimental
Arm Description
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Arm Title
Fovista® plus ranibizumab
Arm Type
Experimental
Arm Description
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Arm Title
Fovista® plus aflibercept
Arm Type
Experimental
Arm Description
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Fovista®
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
Avastin®
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Type
Drug
Intervention Name(s)
aflibercept
Other Intervention Name(s)
Eylea®
Primary Outcome Measure Information:
Title
Total Numer of Systemic Adverse Events
Description
Number of Patients with Systemic Adverse Events
Time Frame
2 years
Title
Total Number of Other Adverse Events (>5%)
Description
Number of Patients with Other Adverse Events
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
City
Huntingdon Valley
State/Province
Pennsylvania
ZIP/Postal Code
19006
Country
United States
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
85014
Country
United States
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data at this time
Learn more about this trial
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)
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