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Completed

NCT Number: NCT01526070

Study of Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Other Therapy for Exudative Age-Related Macular Degeneration

Over the last several years, the standard of care for wet macular degeneration has become treatment with intravitreal injections of ranibizumab (Lucentis, Genentech), administered as frequently as every 4 weeks. In contrast, clinical trials of a soluble VEGF receptor, Aflibercept/VEGF Trap-Eye (Eylea, Regeneron Pharmaceuticals) have demonstrated maintained anatomic and visual improvement with many fewer injections (typically monthly injections for 3 months, followed by every-other-month injections, and as few as 5 injections a year). The purpose of this study is to determine whether patients who have switched from ranibizumab to VEGF Trap-Eye have comparable results.

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Key information

Conditions

Exudative Age-Related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients older than the age of 50 determined by a retinal physician at the Byers Eye Institute at Stanford to have exudative AMD requiring treatment.
  • Patients with an established diagnosis of exudative AMD who have been maintained on a regimen of intravitreal ranibizumab injections.
  • Postmenopausal or negative pregnancy test
  • Patients with an established diagnois of exidative AMD who have been switched from intravitreal ranibizumab to intravitreal VEGF Trap-EYE.

Exclusion criteria

  • Patients with any previous or concurrent history of treatment of other retinal diseases with pharmacologic agents other than ranibizumab, including verteporfin photodynamic therapy, bevacizumab, triamcinolone, or dexamethasone.
  • Patients with prior history of vitrectomy surgery in the study eye.
  • Patients enrolled in any previous or current clinical trial or study of any medication for AMD or any other retinal vascular disease, including diabetic retinopathy or retinal vein occlusion.
  • Ocular media opacity precluding proper retinal imaging
  • Inadequate pupillary dilation to achieve proper retinal imaging
  • Concurrent use of systemic anti-VEGF agents
  • CNV due to other causes, including histoplasmosis, uveitis, trauma, or myopia
  • Active or recent (< 4 weeks) or recurrent inflammation in the eye
  • Current vitreous hemorrhage in the study eye limiting visualization of the fundus
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
  • Untreated glaucoma with IOP > 25 in the eye
  • Other ocular diseases that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy
  • Pregnancy or lactation
  • History of other disease, exam finding, or clinical laboratory that contraindicates the use the drug
  • Current treatment for active systemic infection
  • Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, pulmonary, renal, hepatic, endocrine, or GI disorders
  • History of recurrent significant infections or bacterial infections
  • Inability to comply with study or follow-up procedure

Treatment and study plan

Intravitreal injection of Aflibercept

Drug

Primary outcomes

  1. Visual Acuity

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Standard Therapy for Exudative Age-Related Macular Degeneration

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2012
Registry last updated
Nov 18, 2014

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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