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

Sponsor

Brian Burke, MPH (Other)

Overall Status

Unknown status

CT.gov ID

NCT01581151

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion	Drug: Dexamethasone intravitreal implant Drug: Monthly Ranibizumab	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dexamethasone Implant With Rescue Ranibizumab for Treating Macular Edema Secondary to Retinal Vein Occlusion

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2015

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

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.	Drug: Monthly Ranibizumab 30 days between treatments Other Names: 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

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.

Drug: Monthly Ranibizumab

30 days between treatments

Other Names:

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

Outcome Measures

Primary Outcome Measures

Best Corrected Visual Acuity [6 months]
• Primary outcome: Mean change from baseline in best corrected visual acuity score

Secondary Outcome Measures

Foveal Thickness [6 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.