Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to Retinal Vein Occlusion

Status unconfirmed · Not applicable

Conditions studied: Retinal Vein Occlusion

In brief

This study seeks to compare dexamethasone implant with rescue intravitreal ranibizumab to monthly intravitreal ranibizumab for the treatment of macular edema secondary to branch or central retinal vein occlusion. This is based on the null hypothesis that dexamethasone implant with rescue ranibizumab has inferior best corrected visual acuity at six months compared to monthly ranibizumab alone.

Key facts

Study ID

NCT01581151

Run by

Brian Burke, MPH

People needed

30

Starts

2011-09-01

Expected to finish

2015-06-01

Last updated by the study team

2015-02-20

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent form
• 18 to 90 year-old men or women
• Women must be postmenopausal for at least 12 months before study enrollment, or surgically sterile. Potential child bearing women must have a negative serum pregnancy test within 14 days prior to the first treatment and practice effective contraception during and at least 120 days following the last dose of injection.
• Patient of the Wills Eye Institute Retina service, including all Mid-Atlantic Retina offices.
• Healthy enough to participate in the study.
• Willing and able to consent to participation in the study.
• Retinal vein occlusion:
• Must be diagnosed within two weeks of onset of symptoms
• Best Corrected Visual Acuity (BCVA) on initial presentation between 20/40 and 20/320
• No contraindications to intravitreal injection of dexamethasone implant or ranibizumab
• Central foveal thickness greater than 250 m on Spectral Domain-OCT

You may not qualify if…

• Unknown duration of symptoms prior to diagnosis.
• Patients with any history of prior intravitreal dexamethasone or anti-VEGF or grid laser.
• Patients with diabetic retinopathy.
• Patients with age-related macular degeneration.
• Patients with an optic neuropathy.
• Patients with a retinal detachment or history of retinal detachment.
• Patients with a significant epiretinal membrane.
• Patients with a history of choroidal neovascularization.
• Patients with glaucoma with visual field loss documented on a Humphrey Visual Field test or ocular hypertension requiring more than 2 medications to control IOP in the study eye.
• Patients with a clinically significant media opacity.
• Patients using or anticipating using systemic steroids.
• Patients with any uncontrolled systemic disease.
• Patients with aphakia or anterior-chamber intraocular lens.
• Patients with active neovascularization of the iris, disc, or retina.

Where it is running

• Wills Eye Retina Service — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.