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)
1 other identifier
interventional
63
1 country
24
Brief Summary
To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2016
Shorter than P25 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedStudy Start
First participant enrolled
April 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
March 5, 2019
CompletedOctober 30, 2024
February 1, 2019
8 months
March 9, 2015
October 23, 2018
October 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total Numer of Systemic Adverse Events
Number of Patients with Systemic Adverse Events
2 years
Total Number of Other Adverse Events (>5%)
Number of Patients with Other Adverse Events
2 years
Study Arms (3)
Fovista® plus bevacizumab
EXPERIMENTALFovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Fovista® plus ranibizumab
EXPERIMENTALFovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Fovista® plus aflibercept
EXPERIMENTALFovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Interventions
Eligibility Criteria
You may qualify if:
- Subjects of either gender aged ≥ 50 years.
- Active subfoveal choroidal neovascularization (CNV) due to AMD.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Phoenix, Arizona, 85014, United States
Unknown Facility
Beverly Hills, California, 90211, United States
Unknown Facility
Sacramento, California, 95819, United States
Unknown Facility
Santa Ana, California, 92705, United States
Unknown Facility
New London, Connecticut, 06320, United States
Unknown Facility
Fort Lauderdale, Florida, 33308, United States
Unknown Facility
Fort Myers, Florida, 33912, United States
Unknown Facility
Augusta, Georgia, 30909, United States
Unknown Facility
Oak Forest, Illinois, 60452, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Worcester, Massachusetts, 01605, United States
Unknown Facility
Southfield, Michigan, 48034, United States
Unknown Facility
Minneapolis, Minnesota, 55435, United States
Unknown Facility
Reno, Nevada, 89502, United States
Unknown Facility
Rochester, New York, 14620, United States
Unknown Facility
Cleveland, Ohio, 44130, United States
Unknown Facility
Huntingdon Valley, Pennsylvania, 19006, United States
Unknown Facility
Ladson, South Carolina, 29456, United States
Unknown Facility
Abilene, Texas, 85014, United States
Unknown Facility
Amarillo, Texas, 79106, United States
Unknown Facility
San Antonio, Texas, 78240, United States
Unknown Facility
The Woodlands, Texas, 77384, United States
Unknown Facility
Silverdale, Washington, 98383, United States
Unknown Facility
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Denise Teuber
- Organization
- Ophthotech Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2015
First Posted
March 13, 2015
Study Start
April 26, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
October 30, 2024
Results First Posted
March 5, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.