INTRAVITREAL RANIBIZUMAB THERAPY FOR MACULA EDEMA SECONDARY TO CENTRAL RETINAL VEIN OCCLUSION (RAVO) - RAVO

• Conditions: Macula edema resulting from central retinal vein occlusion in the eye

• Registration Number: EUCTR2006-005450-71-DE
• Lead Sponsor: Augenklinik der LMU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients who at baseline
•have a BCVA letter score in the study eye between finger count5 (1m distance) and 65 (4m distance) (approximately 20/3205/400 5/200 to 20/40 Snellen equivalent and 1,846 – 0,34 logMar) using an ETDRS chart measured at 4 meters or at 1 m.
•have cystoid macular edema secondary to CRVO (ischemic or non ischemic - defined by fluorescein angiography) of =300µm.. In case of development of neovascularistation laser photocoagulation will be performed as recommended by the Central Retinal Vein Occlusion Study
•maximum history of symptoms: 6 months8 weeks
•will be willing to return for all scheduled visits

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•A condition that in the opinion of the investigator would preclude a patient’s participation in the study, e.g., unstable medical status including blood pressure. Patients with hypertension for whom a change in antihypertensive treatment was initiated within 2 months preceding Day 1 should not be enrolled unless blood pressure is maintained for at least 1 month below 150/95 mm Hg by antihypertensive treatment.
•History of systemic (e.g., oral, intravenously, intramuscular, epidural, bursal) corticosteroids within 2 months prior to randomization or topical, rectal, or inhaled corticosteroids in current use more than 2 times per week.
•significant ischaemic heart disease (history of myocardial infarction less than 6 months ago, unstable angina, ischaemic ECG)
•history of heart disease (NYHA grade III-VI)
•history of cerebrovascular event less than 6 months ago
•grossly abnormal urea and electrolytes
•history of significant pulmonary disease
•haematocrit (PCV) below 0,37

Concurrent Ocular Conditions
•Vitreomacular traction or epiretinal membrane in the study eye evident by slit lamp examination or by OCT
•Active intraocular inflammation (grade trace or above) in either eye
•Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated 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), or organized hard exudate plaques
•Ocular disorders in the study eye that may confound interpretation of study results, including 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 28-week12-month study period
•History of uncontrolled glaucoma (defined as intraocular pressure =25 mm Hg despite treatment with anti-glaucoma medication) or low tension glaucoma in the study eye
•History of glaucoma filtration surgery, corneal transplant surgery in the study eye
•Ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for three or more consecutive days at any time within 6 months prior to screening or during the course of the study

Systemic Conditions
•Blood pressure: Systolic = 150 mmHg and/or Diastolic = 95 mmHg
oIf blood pressure is brought and maintained for at least 1 month below 150/95 mm Hg by antihypertensive treatment, patient can become eligible
•History of chronic renal failure requiring dialysis or kidney transplant
•Pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization; use of oral contraceptives; barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel; an IUD; or contraceptive hormone implant or patch
•Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/ml)
•Current treatment for active systemic infection
•Current

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified