A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion

Completed · Phase 4

Conditions studied: Macular Edema

In brief

This was a Phase IV multicenter, randomized, open-label study, with masking of the vision examiner, of the efficacy and safety of intravitreal ranibizumab 0.5 mg in subjects with macular edema following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO).

Key facts

Study ID

NCT01277302

Run by

Genentech, Inc.

People needed

202

Starts

2011-02-01

Expected to finish

2012-10-01

Last updated by the study team

2014-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study.
• Ocular Inclusion Criteria (Study Eye)
• Foveal center-involved macular edema secondary to branch retinal vein occlusion (BRVO) (including hemi-retinal retinal vein occlusion [HRVO]) or central retinal vein occlusion (CRVO).
• Best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts of 20/40 to 20/320 (Snellen equivalent) in the study eye.
• Mean central subfield thickness > 300 µm on 2 spectral-domain optical coherence tomography measurements (screening and Day 0 [first day of treatment]).

You may not qualify if…

• History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.
• History of any systemic anti-vascular endothelial growth factor (VEGF) or pro-VEGF treatment within 6 months prior to Day 0.
• History of allergy to fluorescein.
• History of allergy to ranibizumab injection or related molecule.
• Relevant systemic disease that may be associated with increased systemic VEGF levels. History of successfully treated malignancies is not an exclusion criterion.
• Uncontrolled blood pressure.
• Pregnancy or lactation.
• Daily use of oral corticosteroids to treat a chronic condition.
• Required treatment with injectable corticosteroids to treat a musculoskeletal condition.
• Participation in an investigational trial within 30 days prior to Day 0 that involved treatment with any drug or device that has not received regulatory approval at the time of study entry.
• Ocular Exclusion Criteria (Study Eye)
• Prior episode of retinal vein occlusion (RVO).
• Brisk afferent pupillary defect.
• History of any previous intravitreal anti-VEGF therapy for RVO in the study eye.
• History of previous therapeutic treatment for RVO, other than anti-VEGF therapy, within 4 months prior to the screening visit, including any intraocular corticosteroids.
• History of previous surgical treatment for RVO, including radial optic neurotomy or sheathotomy.
• History or presence of age-related macular degeneration (AMD) (dry form graded as Age-Related Eye Disease Study [AREDS] Stage 2 or higher or wet form).
• History of laser photocoagulation for macular edema within 4 months prior to Day 0.
• History of panretinal scatter photocoagulation or sector laser photocoagulation within 4 months prior to Day 0 or anticipated within the next 4 months following Day 0.
• History of pars plana vitrectomy.
• History of intraocular surgery within 2 months prior to Day 0 or anticipated within the next 7 months following Day 0.
• History of yttrium-aluminum-garnet (YAG) capsulotomy performed within 2 months prior to Day 0.
• Previous filtration surgery in the study eye.
• History of herpetic ocular infection.
• History of ocular toxoplasmosis.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Chico, California, United States
• Study site — Mountain View, California, United States
• Study site — Oakland, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Ana, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Torrance, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Golden, Colorado, United States
• Study site — New London, Connecticut, United States
• Study site — Altamonte Springs, Florida, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Lakeland, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Hagerstown, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Jackson, Michigan, United States
• Study site — Edina, Minnesota, United States
• Study site — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.