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 |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 3/7/2019 |
Start Date: | April 26, 2016 |
End Date: | January 2017 |
To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with
anti-VEGF therapy.
anti-VEGF therapy.
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).
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).
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.
We found this trial at
24
sites
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