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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01526070
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : November 18, 2014
Information provided by (Responsible Party):
Theodore Leng, 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.

Condition or disease Intervention/treatment
Exudative Age-related Macular Degeneration Drug: Intravitreal injection of Aflibercept

Study Type : Observational
Actual Enrollment : 142 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Standard Therapy for Exudative Age-Related Macular Degeneration
Study Start Date : January 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients with Exudative Age-Related Macular Degeneration
Patients with eAMD who received intravitreal thearpy
Drug: Intravitreal injection of Aflibercept

Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with exudative age-related macular degeneration

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526070

United States, California
Byers Eye Institute at Stanford
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Stanford University

Responsible Party: Theodore Leng, Clinical Assistant Professor of Ophthalmology, Stanford University Identifier: NCT01526070     History of Changes
Other Study ID Numbers: SU-02012012-9068
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases