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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | 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). |
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| Part B | Active Comparator | 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. |
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| Part C | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEGF Trap | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability, bioeffect | From baseline to Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of VEGF Trap administration on excess central retinal/lesion thickness | From baseline to Day 43 | |
| Best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity | From baseline to Day 43 |
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Inclusion Criteria:
Subfoveal CNV secondary to AMD.
Central retinal/lesion thickness ≥ 250µm as measured by optical coherence tomography (OCT).
ETDRS best-corrected visual acuity of:
Clear ocular media and clear lens(es) to permit good quality stereoscopic fundus photography.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avner Ingerman, MD | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Centers, PC | Tuscon | Arizona | 85704 | United States | ||
| Loma Linda University Health Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22775078 | Result | Nguyen QD, Campochiaro PA, Shah SM, Browning DJ, Hudson HL, Sonkin PL, Hariprasad SM, Kaiser PK, Slakter J, Haller JA, Do DV, Mieler W, Chu K, Ingerman A, Vitti R, Berliner AJ, Cedarbaum J; Clear-It 1 Investigators. Evaluation of very high- and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration. J Ocul Pharmacol Ther. 2012 Dec;28(6):581-8. doi: 10.1089/jop.2011.0261. Epub 2012 Jul 9. | |
| 21546089 |
| Label | URL |
|---|---|
| Related Info | View source |
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| Extent of CNV leakage | From baseline to Day 43 |
| Anti-VEGF Trap antibodies in the systemic circulation | From baseline to Day 43 |
| Plasma levels of VEGF Trap | From baseliene to Day 43 |
| Loma Linda |
| California |
| 92354 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins Hospital School of Medicine | Baltimore | Maryland | 21287 | United States |
| Charlotte Eye, Ear, Nose & Throat Asssociates | Charlotte | North Carolina | 28120 | United States |
| Dean A. McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Retina Diagnostic and Treatment Assoc., LLC | Philadelphia | Pennsylvania | 19107 | United States |
| Retina-Vitreous Associates, P.C. | Nashville | Tennessee | 37203 | United States |
| Result |
| Do DV, Schmidt-Erfurth U, Gonzalez VH, Gordon CM, Tolentino M, Berliner AJ, Vitti R, Ruckert R, Sandbrink R, Stein D, Yang K, Beckmann K, Heier JS. The DA VINCI Study: phase 2 primary results of VEGF Trap-Eye in patients with diabetic macular edema. Ophthalmology. 2011 Sep;118(9):1819-26. doi: 10.1016/j.ophtha.2011.02.018. Epub 2011 May 5. |
| Related Info | View source |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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