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

NCT01581151 | Unknown

• 1 other identifier: WE IRB# 11-122
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinal Vein Occlusion

Keywords

retinal vein occlusion; ozurdex; lucentis; BCVA; foveal thickness

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity

  • Primary outcome: Mean change from baseline in best corrected visual acuity score

  6 months

Secondary Outcomes (1)

• Foveal Thickness

  6 months

Study Arms (2)

Monthly Ranibizumab

ACTIVE COMPARATOR

• Patients will receive a ranibizumab intravitreal injection on day 0. During each other visit, patients will receive a ranibizumab intravitreal injection. The protocol will use the term "monthly" to represent a 30 day interval between treatments.

Drug: Monthly Ranibizumab

Dexamethasone intravitreal implant

EXPERIMENTAL

* Patients will receive a dexamethasone intravitreal implant injection at day 0. * During monthly visits 1,2,3, and 5, patients will receive a ranibizumab intravitreal injection if the macula SD-OCT during that visit shows mean central foveal thickness ≥ 250 μm or the best-corrected visual acuity is 20/40 or worse. The injection procedure is described in the next section. * During monthly visit 4, patients will receive a dexamethasone intravitreal implant injection if the macula SD-OCT during that visit shows mean central foveal thickness ≥ 250 μm or the best-corrected visual acuity is 20/40 or worse.

Drug: Dexamethasone intravitreal implant

Interventions

Dexamethasone intravitreal implant DRUG

Patients will receive a Dexamethasone implant and ranibizumab, as needed. A comparison will be made between ranibizumab and Dexamethasone implant with rescue ranibizumab.

Also known as: Ozurdex - Allergan, Ranibizumab - Genentech

Dexamethasone intravitreal implant

Monthly Ranibizumab DRUG

30 days between treatments

Also known as: Ranibizumab

Monthly Ranibizumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form
• 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.

Sponsors & Collaborators

• Brian Burke, MPH: lead

Study Sites (1)

Wills Eye Retina Service

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Dexamethasone; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Brianna Kenney

CONTACT

research@midatlanticretina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 20, 2012
• Study Start: September 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 20, 2015

Record last verified: 2015-02

Locations

US (1)