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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Wills Eye
Sponsor:
Information provided by (Responsible Party):
Brian Burke, MPH, Wills Eye
ClinicalTrials.gov Identifier:
NCT01581151
First received: April 17, 2012
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Retinal Vein Occlusion
Drug: Dexamethasone intravitreal implant
Drug: Monthly Ranibizumab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dexamethasone Implant With Rescue Ranibizumab for Treating Macular Edema Secondary to Retinal Vein Occlusion

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Best Corrected Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • Primary outcome: Mean change from baseline in best corrected visual acuity score


Secondary Outcome Measures:
  • Foveal Thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Monthly Ranibizumab
30 days between treatments
Other Name: Ranibizumab
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.
Drug: 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.
Other Names:
  • Ozurdex - Allergan
  • Ranibizumab - Genentech

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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581151

Contacts
Contact: Noga Senderowitsch research@midatlanticretina.com

Locations
United States, Pennsylvania
Wills Eye Retina Service Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jessica Jordan    215-928-3092    research@midatlanticretina.com   
Principal Investigator: Julia A. Haller, MD         
Sub-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         
Sponsors and Collaborators
Brian Burke, MPH
  More Information

No publications provided

Responsible Party: Brian Burke, MPH, Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01581151     History of Changes
Other Study ID Numbers: WE IRB# 11-122
Study First Received: April 17, 2012
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
retinal vein occlusion
ozurdex
lucentis
BCVA
foveal thickness

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014