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

Not Recruiting

Trial ID: NCT01526070


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.

Official Title

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

Stanford Investigator(s)

Theodore Leng, MD, FACS
Theodore Leng, MD, FACS

Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)


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.

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


drug: Intravitreal injection of Aflibercept

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Theodore Leng, MD