- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01581151
Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to Retinal Vein Occlusion
February 19, 2015 updated by: Brian Burke, MPH
Dexamethasone Implant With Rescue Ranibizumab for Treating Macular Edema Secondary to Retinal Vein Occlusion
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brianna Kenney
- Email: research@midatlanticretina.com
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Wills Eye Retina Service
-
Contact:
- Jessica Jordan
- Phone Number: 215-928-3092
- Email: research@midatlanticretina.com
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Principal Investigator:
- Julia A. Haller, MD
-
Sub-Investigator:
- Allen Chiang, MD
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Sub-Investigator:
- Ehsan Rahimy, MD
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Sub-Investigator:
- Allen Ho, MD
-
Sub-Investigator:
- Sunir Garg, MD
-
Sub-Investigator:
- Carl Regillo, MD
-
Sub-Investigator:
- Marc Spirn, MD
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Sub-Investigator:
- Sonia Mehta, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
30 days between treatments
Other Names:
|
Experimental: 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Corrected Visual Acuity
Time Frame: 6 months
|
• Primary outcome: Mean change from baseline in best corrected visual acuity score
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foveal Thickness
Time Frame: 6 months
|
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Anticipated)
June 1, 2015
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
April 17, 2012
First Submitted That Met QC Criteria
April 19, 2012
First Posted (Estimate)
April 20, 2012
Study Record Updates
Last Update Posted (Estimate)
February 20, 2015
Last Update Submitted That Met QC Criteria
February 19, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Macular Degeneration
- Macular Edema
- Retinal Vein Occlusion
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dexamethasone
- Ranibizumab
Other Study ID Numbers
- WE IRB# 11-122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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