Recruiting

Ozurdex with Lucentis

Sponsor:

Brian Burke, MPH

Code:

NCT01581151

Conditions

Retinal Vein Occlusion

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone intravitreal implant

Monthly Ranibizumab

Study Details

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

Study ID

NCT01581151

Start date

Sep, 2011

Status verified date

Feb, 2015

Completion date

Jun, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Monthly Ranibizumab

• 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.

experimental: Dexamethasone intravitreal implant

  • 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.

Interventions

Dexamethasone intravitreal implant

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

Monthly Ranibizumab

30 days between treatments

Primary outcome measure

  • Best Corrected Visual Acuity [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Brianna Kenney

research@midatlanticretina.com

Locations

Wills Eye Retina Service

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Jessica Jordan

215-928-3092research@midatlanticretina.com

Principal Investigator:

Julia A. Haller, MD

More Information

Sponsor

Brian Burke, MPH

Last update posted

Feb 20, 2015

Last verified

Feb, 2015

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Brian Burke, MPH on 2015-02-20.