Overview

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

Status:
Unknown status
Trial end date:
2015-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brian Burke, MPH
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Ranibizumab
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.