Macular Degeneration
Conditions
Keywords
Neovascular Age-Related Macular Degeneration
Brief summary
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.
Detailed description
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.
Interventions
DRUGVEGF 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.
Sponsors
Bayer
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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: * 20/40 (73 letters) or worse * Clear ocular media and clear lens(es) to permit good quality stereoscopic fundus photography.
Exclusion criteria
* Prior treatment with VEGF Trap, bevacizumab or ranibizumab. * Any investigational agent within 12 weeks of Visit 2 (Day 1). * Presence of other causes of CNV. * Active ocular infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, bioeffect | From baseline to Day 43 |
Secondary
| Measure | 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 |
| 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 |
Countries
United States
Outcome results
None listed