Status:
COMPLETED
Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions
Lead Sponsor:
Peter A Campochiaro, MD
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Macular Edema
Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Central and branch retinal vein occlusions are major causes of visual loss. Hemorrhage and capillary nonperfusion, when they involve the macula, can contribute to visual loss, but the major cause is m...
Detailed Description
This study is a phase II, open-label study to investigate the bioactivity and pharmacodynamics of intravitreous ranibizumab in subjects with macular edema due to central and branch retinal vein occlus...
Eligibility Criteria
Inclusion
- Signed informed consent and authorization of use and disclosure of protected health information
- Age greater than or equal to 18 years
- Diagnosis of macular edema due to central or branch retinal vein occlusion
- Foveal thickness of over 250 um, as assessed by OCT
- Best corrected visual acuity score in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled. Visual acuity score in the non-study eye must be greater than 25 letters (approximate Snellen equivalent 20/320).
- In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from vein occlusion and not from other obvious causes of decreased vision
- In the opinion of the investigator, laser photocoagulation can be withheld for at least 30 days after the patient has enrolled in the study
Exclusion
- Prior/Concomitant Treatment
- Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
- Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry
- Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium \[EYE001\], ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 3 months of study entry Concurrent Ocular Conditions
- Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT
- Ocular inflammation (including 1+ or above in the amount of cells) in the study eye
- History of idiopathic or autoimmune uveitis in either eye
- Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque
- Ocular disorders in the study eye that may confound interpretation of study results, including diabetic retinopathy, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia)
- Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period
- Intraocular surgery in the study eye within 3 months of study entry
- During the study, if patients need to have cataract surgery, the patients will undergo the necessary cataract or any other surgery and will continued to be treated per protocol and followed.
- Uncontrolled glaucoma (defined as intraocular pressure greater than 30 mm Hg despite treatment with anti-glaucoma medication) or previous filtration surgery in the study eye
- Infectious blepharitis, keratitis, scleritis, or conjunctivitis (in either eye) or current treatment for serious systemic infection Systemic Conditions
- Blood pressure exceeding 160/95 (sitting) during the screening period
- Renal failure requiring dialysis or renal transplant
- Premenopausal women not using adequate contraception
- Previous participation in other studies of investigational drugs (excluding vitamins and minerals) within 3 months
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00407355
Start Date
January 1 2006
End Date
February 1 2013
Last Update
December 4 2013
Active Locations (1)
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1
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287