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

NCT01526070 | Completed

• 1 other identifier: SU-02012012-9068
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exudative Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  1 year

Study Arms (1)

Patients with Exudative Age-Related Macular Degeneration

Patients with eAMD who received intravitreal thearpy

Drug: Intravitreal injection of Aflibercept

Interventions

Intravitreal injection of Aflibercept DRUG

Patients with Exudative Age-Related Macular Degeneration

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with exudative age-related macular degeneration

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 3, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

US (1)