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Completed

NCT Number: NCT00527423

Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD

Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.

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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 2

Primary location

Peoria, Arizona, United States

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About this study

Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prior participation in VEGF Trap-Eye Phase I and II studies

Exclusion criteria

  • Any ocular or systemic adverse events that would preclude participation
  • Presence of any condition that would jeopardize subject's participation

Treatment and study plan

VEGF Trap Eye

Drug

Intravitreal injection

Other names: IVT

Primary outcomes

  1. Number of Participants With Adverse Events (AE)

    Time frame: Baseline of this study to Wk 152

    Number of participants with AEs summarized by category

Secondary outcomes

  1. Frequency (Number of Injections)

    Time frame: Baseline of this study to Wk 152

    Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).

  2. Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values

    Time frame: Baseline of original study to Wk 156

    Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Bayer

Registry information

Official study title

A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 10, 2007
Registry last updated
Jun 12, 2013

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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