A Phase 1 interventional study of VEGF Trap in Macular Degeneration, sponsored by Regeneron Pharmaceuticals. Completed at 8 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment
The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
This study consists of three parts, Part A, Part B and Part C. Part A is a dose escalation. Part B was terminated early. The (one) subject who received Macugen is not discussed in this website. Part C had subjects receive one of two doses of VEGF Trap (0.15 mg or 4.0 mg).
This is the first study in which human subjects received intravitreal injections of VEGF Trap in a study eye.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 51 is close to the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
ETDRS best-corrected visual acuity of:
Exclusion Criteria:
Part A: An open label study in which six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. The total volume of each injection will be 100 μL. Enrollment in new dose levels will not begin until all patients in the preceding dose level have completed Visit 5 (Day 15).
Drug: VEGF Trap
Part B: A controlled, prospective, randomized, double-masked study in which up to 30 subjects meeting eligibility criteria will be randomly assigned in a 1:1 ratio to receive a single ITV injection of2.0 mg/eye VEGF Trap (or the MTD if reached prior to 2.0 mg) followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Enrollment into Part B will begin 2 weeks after the last subject to receive the 2.0 mg/eye dose in Part A has been observed for 15 days and it has been determined that the safety profile of VEGF Trap at this dose level is adequate to support expansion of dosing at this dose level. The dose of pegaptanib sodium will be 0.3 mg, according to the package insert.
Drug: VEGF Trap
Part C: A controlled, prospective, randomized, double-masked study in which approximately 30 subjects meeting eligibility criteria will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. Initiation of Part C is contingent upon the 4.0 mg dose being adequately tolerated in Part A.
Drug: VEGF Trap
Part A: Six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. Part B: Up to 30 subjects will be randomly assigned in a 1:1 ratio to receive a single of 2.0 mg/eye VEGF Trap followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Part C: Approximately 30 subjects will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. After completion of Visit 8 (Day 57), patients from all parts of the study, may be eligible to continue in Open-label Extension and will receive 4.0 mg of VEGF Trap.
Also known as: Aflibercept
Safety and tolerability, bioeffect
Time frame: From baseline to Day 43
The effect of VEGF Trap administration on excess central retinal/lesion thickness
Time frame: From baseline to Day 43
Best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity
Time frame: From baseline to Day 43
Extent of CNV leakage
Time frame: From baseline to Day 43
Anti-VEGF Trap antibodies in the systemic circulation
Time frame: From baseline to Day 43
Plasma levels of VEGF Trap
Time frame: From baseliene to Day 43
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Regeneron Pharmaceuticals