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OpenTrials
Completed

NCT Number: NCT00320775

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

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Retina Centers, PC, Tuscon, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Aflibercept

Primary outcomes

  1. Safety and tolerability, bioeffect

    Time frame: From baseline to Day 43

Secondary outcomes

  1. The effect of VEGF Trap administration on excess central retinal/lesion thickness

    Time frame: From baseline to Day 43

  2. Best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity

    Time frame: From baseline to Day 43

  3. Extent of CNV leakage

    Time frame: From baseline to Day 43

  4. Anti-VEGF Trap antibodies in the systemic circulation

    Time frame: From baseline to Day 43

  5. Plasma levels of VEGF Trap

    Time frame: From baseliene to Day 43

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Bayer

Registry information

Official study title

An Exploratory Study of the Safety, Tolerability and Biological Effect of Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 3, 2006
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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