Retinal Vein OcclusionNCT01581151
Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to Retinal Vein Occlusion
A study testing Dexamethasone intravitreal implant and Monthly Ranibizumab in people with Retinal Vein Occlusion, run by Brian Burke, MPH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- Dexamethasone intravitreal implant and Monthly Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Brianna Kenney contact
United States1 site, 1 recruiting
- Recruiting
Wills Eye Retina Service
Philadelphia, Pennsylvania, 19107
Jessica Jordan, 215-928-3092, research@midatlanticretina.com
Julia A. Haller, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Retinal Vein Occlusion
- Being tested
- Dexamethasone intravitreal implant, Monthly Ranibizumab
- Keywords
- retinal vein occlusion, ozurdex, lucentis, BCVA, foveal thickness
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone intravitreal implantDrug
Also called Ozurdex - Allergan, Ranibizumab - Genentech
Patients will receive a Dexamethasone implant and ranibizumab, as needed. A comparison will be made between ranibizumab and Dexamethasone implant with rescue ranibizumab.
Monthly RanibizumabDrug
Also called Ranibizumab
30 days between treatments
| Study group | Role | What they receive |
|---|---|---|
| Monthly Ranibizumab | Active comparator | • 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. Receives: Drug: Monthly Ranibizumab |
| Dexamethasone intravitreal implant | Experimental | * 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. Receives: Drug: Dexamethasone intravitreal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
- Primary outcome: Mean change from baseline in best corrected visual acuity score
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brian Burke, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian Burke, MPH, Wills Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581151
- Sponsor's protocol ID
- WE IRB# 11-122
- Status last verified
- Feb 2015
- First submitted
- 17 Apr 2012
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Implant With Rescue Ranibizumab for Treating Macular Edema Secondary to Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT01581151
- Acronym / sponsor ID
- WE IRB# 11-122
- Conditions
- Retinal Vein Occlusion
- Keywords
- retinal vein occlusion, ozurdex, lucentis, BCVA, foveal thickness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brian Burke, MPHUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monthly Ranibizumab | Active comparator | Drug: 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. |
| Dexamethasone intravitreal implant | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone intravitreal implantAlso: Ozurdex - Allergan, Ranibizumab - GenentechPatients will receive a Dexamethasone implant and ranibizumab, as needed. A comparison will be made between ranibizumab and Dexamethasone implant with rescue ranibizumab. | Drug | Dexamethasone intravitreal implant |
| Monthly RanibizumabAlso: Ranibizumab30 days between treatments | Drug | Monthly Ranibizumab |
Primary outcome
Best Corrected Visual Acuity
Time frame: 6 months
• Primary outcome: Mean change from baseline in best corrected visual acuity score
1 secondary outcome
Foveal Thickness
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brianna Kenney contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone intravitreal implant and Monthly Ranibizumab in people with Retinal Vein Occlusion, run by Brian Burke, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brianna Kenney (research@midatlanticretina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2015.