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

Primary Purpose

Retinal Vein Occlusion

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone intravitreal implant
Monthly Ranibizumab
Sponsored by
Brian Burke, MPH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring retinal vein occlusion, ozurdex, lucentis, BCVA, foveal thickness

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wills Eye Retina ServiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Monthly Ranibizumab

Dexamethasone intravitreal implant

Arm Description

• 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.

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.

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity
• Primary outcome: Mean change from baseline in best corrected visual acuity score

Secondary Outcome Measures

Foveal Thickness
Mean absolute change from baseline in central foveal thickness, Proportion of subjects with a central foveal thickness 250m Mean change in fluid and central foveal thickness on OCT Time Frame Proportion of subjects who gain at least 15 letters in BCVA score Proportion of subjects who lose fewer than 15 letters in BCVA score The incidence of ocular and systemic adverse events Mean change from baseline in the NEI VFQ 25 near activities Mean change from baseline in the NEI VFQ 25 distance activities

Full Information

First Posted
April 17, 2012
Last Updated
February 19, 2015
Sponsor
Brian Burke, MPH
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1. Study Identification

Unique Protocol Identification Number
NCT01581151
Brief Title
Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to Retinal Vein Occlusion
Official Title
Dexamethasone Implant With Rescue Ranibizumab for Treating Macular Edema Secondary to Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brian Burke, MPH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) and Ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA) as needed group: Patients will receive a dexamethasone intravitreal implant injection at day 0. Injection procedure will be identical to those previously described.8,19,20 Topical tetracaine drops will be given, a lid speculum inserted, and then 5% povidone iodine drops will be given. After subconjunctival injection of 2% lidocaine, the 0.7mg DEX implant will be inserted through the pars plana using a customized, single use, 22-gauge applicator. Patients will be treated with topical ophthalmic antibiotics four times daily for three days after the procedure. 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. Monthly Ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA) group: 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. The minimal interval between treatments may be 25 days. Injection procedures will be identical to those previously described.8,19,20 Topical tetracaine drops will be given, a lid speculum inserted, and then 5% povidone iodine drops will be given. After subconjunctival injection of 2% lidocaine, a 30-gauge needle will be inserted through the pars plana, and 0.5 mg (0.05mL) of drug injected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
Keywords
retinal vein occlusion, ozurdex, lucentis, BCVA, foveal thickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monthly Ranibizumab
Arm Type
Active Comparator
Arm Description
• 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.
Arm Title
Dexamethasone intravitreal implant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone intravitreal implant
Other Intervention Name(s)
Ozurdex - Allergan, Ranibizumab - Genentech
Intervention Description
Patients will receive a Dexamethasone implant and ranibizumab, as needed. A comparison will be made between ranibizumab and Dexamethasone implant with rescue ranibizumab.
Intervention Type
Drug
Intervention Name(s)
Monthly Ranibizumab
Other Intervention Name(s)
Ranibizumab
Intervention Description
30 days between treatments
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Description
• Primary outcome: Mean change from baseline in best corrected visual acuity score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Foveal Thickness
Description
Mean absolute change from baseline in central foveal thickness, Proportion of subjects with a central foveal thickness 250m Mean change in fluid and central foveal thickness on OCT Time Frame Proportion of subjects who gain at least 15 letters in BCVA score Proportion of subjects who lose fewer than 15 letters in BCVA score The incidence of ocular and systemic adverse events Mean change from baseline in the NEI VFQ 25 near activities Mean change from baseline in the NEI VFQ 25 distance activities
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brianna Kenney
Email
research@midatlanticretina.com
Facility Information:
Facility Name
Wills Eye Retina Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Jordan
Phone
215-928-3092
Email
research@midatlanticretina.com
First Name & Middle Initial & Last Name & Degree
Julia A. Haller, MD
First Name & Middle Initial & Last Name & Degree
Allen Chiang, MD
First Name & Middle Initial & Last Name & Degree
Ehsan Rahimy, MD
First Name & Middle Initial & Last Name & Degree
Allen Ho, MD
First Name & Middle Initial & Last Name & Degree
Sunir Garg, MD
First Name & Middle Initial & Last Name & Degree
Carl Regillo, MD
First Name & Middle Initial & Last Name & Degree
Marc Spirn, MD
First Name & Middle Initial & Last Name & Degree
Sonia Mehta, MD

12. IPD Sharing Statement

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

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