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

Completed

• Conditions: Exudative Age-related Macular Degeneration
• Interventions: Drug: Intravitreal injection of Aflibercept

• Registration Number: NCT01526070
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. 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.
2. Patients with an established diagnosis of exudative AMD who have been maintained on a regimen of intravitreal ranibizumab injections.
3. Postmenopausal or negative pregnancy test
4. Patients with an established diagnois of exidative AMD who have been switched from intravitreal ranibizumab to intravitreal VEGF Trap-EYE.

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Exclusion Criteria

1. 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.
2. Patients with prior history of vitrectomy surgery in the study eye.
3. 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.
4. Ocular media opacity precluding proper retinal imaging
5. Inadequate pupillary dilation to achieve proper retinal imaging
6. Concurrent use of systemic anti-VEGF agents
7. CNV due to other causes, including histoplasmosis, uveitis, trauma, or myopia
8. Active or recent (< 4 weeks) or recurrent inflammation in the eye
9. Current vitreous hemorrhage in the study eye limiting visualization of the fundus
10. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
11. Untreated glaucoma with IOP > 25 in the eye
12. Other ocular diseases that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy
13. Pregnancy or lactation
14. History of other disease, exam finding, or clinical laboratory that contraindicates the use the drug
15. Current treatment for active systemic infection
16. Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, pulmonary, renal, hepatic, endocrine, or GI disorders
17. History of recurrent significant infections or bacterial infections
18. Inability to comply with study or follow-up procedure

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Exudative Age-Related Macular Degeneration	Intravitreal injection of Aflibercept	Patients with eAMD who received intravitreal thearpy

Primary Outcome Measures

Name	Time	Method
Visual Acuity	1 year

Trial Locations

Locations (1)

Byers Eye Institute at Stanford; 🇺🇸 Palo Alto, California, United States