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

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

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

NCT01526070•Stanford University

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (1)

Byers Eye Institute at Stanford

Palo Alto, California, United States

Key Dates

Start Date

January 1, 2012

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2014

Last Updated

November 18, 2014

Enrollment

142

ACTUAL participants

Conditions

Exudative Age-related Macular Degeneration

Interventions

Intravitreal injection of Aflibercept

DRUG

A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration

NCT04200248

Exudative Age-related Macular Degeneration

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COMPLETEDPHASE1/PHASE2

Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

NCT05703867

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration

Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration

Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD

ESBA1008 Microvolume Study

LUCAS (Lucentis Compared to Avastin Study)