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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Theodore Leng, Stanford University
ClinicalTrials.gov Identifier:
NCT01526070
First received: February 1, 2012
Last updated: February 11, 2012
Last verified: February 2012
  Purpose

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 Intervention
Exudative Age-related Macular Degeneration
Drug: Intravitreal injection of Aflibercept

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Estimated Enrollment: 590
Study Start Date: January 2012
Groups/Cohorts Assigned Interventions
Patients with Exudative Age-Related Macular Degeneration Drug: Intravitreal injection of Aflibercept

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with exudative age-related macular degeneration

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526070

Contacts
Contact: Theodore Leng, MD 650-723-6995

Locations
United States, California
Byers Eye Institute at Stanford Recruiting
Palo Alto, California, United States, 94303
Contact: Theodore Leng, MD    650-723-6995      
Principal Investigator: Theodore Leng, MD         
Sponsors and Collaborators
Stanford University
  More Information

No publications provided

Responsible Party: Theodore Leng, Clinical Assistant Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT01526070     History of Changes
Other Study ID Numbers: SU-02012012-9068
Study First Received: February 1, 2012
Last Updated: February 11, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014