Status:
COMPLETED
Study of Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Other Therapy for Exudative Age-Related Macular Degeneration
Lead Sponsor:
Stanford University
Conditions:
Exudative Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
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 eve...
Eligibility Criteria
Inclusion
- 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.
- Patients with an established diagnosis of exudative AMD who have been maintained on a regimen of intravitreal ranibizumab injections.
- Postmenopausal or negative pregnancy test
- Patients with an established diagnois of exidative AMD who have been switched from intravitreal ranibizumab to intravitreal VEGF Trap-EYE.
Exclusion
- 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.
- Patients with prior history of vitrectomy surgery in the study eye.
- 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.
- Ocular media opacity precluding proper retinal imaging
- Inadequate pupillary dilation to achieve proper retinal imaging
- Concurrent use of systemic anti-VEGF agents
- CNV due to other causes, including histoplasmosis, uveitis, trauma, or myopia
- Active or recent (\< 4 weeks) or recurrent inflammation in the eye
- Current vitreous hemorrhage in the study eye limiting visualization of the fundus
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
- Untreated glaucoma with IOP \> 25 in the eye
- Other ocular diseases that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy
- Pregnancy or lactation
- History of other disease, exam finding, or clinical laboratory that contraindicates the use the drug
- Current treatment for active systemic infection
- Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, pulmonary, renal, hepatic, endocrine, or GI disorders
- History of recurrent significant infections or bacterial infections
- Inability to comply with study or follow-up procedure
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT01526070
Start Date
January 1 2012
End Date
July 1 2014
Last Update
November 18 2014
Active Locations (1)
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1
Byers Eye Institute at Stanford
Palo Alto, California, United States, 94303