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

Exudative Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526070
• Other study ID #: SU-02012012-9068
• Status: Completed
• Phase: N/A
• First received: February 1, 2012
• Last updated: November 17, 2014
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exudative Age-related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Intravitreal injection of Aflibercept

Locations

Country	Name	City	State
United States	Byers Eye Institute at Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity		1 year	No