Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Macular Degeneration

Treatments: Drug: VEGF Trap

Study type: Interventional

Funder types: Industry

Identifiers

NCT00320775

VGFT-OD-0502

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 3 patient groups

Part A

Experimental group

Description:

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).

Treatment:

Drug: VEGF Trap

Part B

Active Comparator group

Description:

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.

Treatment:

Drug: VEGF Trap

Part C

Active Comparator group

Description:

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.

Treatment:

Drug: VEGF Trap