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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Brian Burke, MPH
Study ID
NCT01581151
Status
Unknown

Conditions

  • Retinal Vein Occlusion

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

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.
  • Monthly Ranibizumab — DRUG
    30 days between treatments

Study Details

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 Dates

First listed
Apr 20, 2012
Start date
Sep 30, 2011
Status verified
Feb 2015
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Best Corrected Visual Acuity [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wills Eye Retina ServicePhiladelphiaPennsylvania19107
Jessica Jordan
[email protected]
215-928-3092
Julia A. Haller, MD (PRINCIPAL_INVESTIGATOR)
Allen Chiang, MD (SUB_INVESTIGATOR)
Ehsan Rahimy, MD (SUB_INVESTIGATOR)
Allen Ho, MD (SUB_INVESTIGATOR)
Sunir Garg, MD (SUB_INVESTIGATOR)
Carl Regillo, MD (SUB_INVESTIGATOR)
Marc Spirn, MD (SUB_INVESTIGATOR)
Sonia Mehta, MD (SUB_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By research site
Wills Eye Retina Service· Philadelphia, PA

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