Phase 2
N=40
Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions
Macular Edema · Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT00407355 ↗Enrolled (actual)
40
Serious AEs
35.0%
Results posted
Dec 2013
Primary outcome: Primary: Best Corrected Visual Acuity Change From Baseline at All Visits — 10.5; 15.1 ETDRS letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intravitreal injection of ranibizumab .3 dose (Drug); Intravitreal injection of Ranibizumab .5 dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Peter A Campochiaro, MD
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Corrected Visual Acuity Change From Baseline at All Visits |
10.5; 15.1 | — |
| PRIMARY Retinal Thickness Change From Baseline at All Visits |
-379.9; -216.9 | — |
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 macular edema. Focal and grid laser photocoagulation can sometimes provide benefit in patients with macular edema due to branch vein occlusions, but several laser treatments are often needed and recovery of vision can be very slow and incomplete 1. Laser photocoagulation does not provide benefit for macular edema due to central vein occlusions 2. Therefore, new treatments are needed.The objective of this study is to assess the bioactivity of 3 intravitreous injections 0.5 mg or 0.3 mg of ranibizumab in patients with macular edema due to central and branch retinal vein occlusions and correlate activity with peak and trough aqueous levels. The purpose of this research protocol is pilot study to determine if a randomized placebo controlled trial is warranted.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00407355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.