INTRAOCULAR BEVACIZUMAB (AVASTIN™) FOR CENTRAL AND BRANCH RETINAL VEIN OCCLUSION STUDY

Phase 1

• Conditions: CENTRAL AND BRANCH RETINAL VEIN OCCLUSIO

• Registration Number: EUCTR2005-003288-21-AT
• Lead Sponsor: Dept. of Ophthalmology, Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-24
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Signed informed consent
•CRVO or BRVO
•No requirement for panretinal laser coagulation
•No active proliferative disease (NVD/NVE/rubeosis)
•Patients with BRVO will only included if vision is better than 0.4 or if previous focal laser coagulation has shown no significant improvement in vision.
•Retinal thickness of at least 250µm due to intraretinal or subretinal edema as measured by OCT.

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

Prior/Concomitant Treatment
•Previous vitrectomy
•Laser coagulation within the last 3 month
•Previous participation in any studies of investigational drugs within 3 month preceding Day 0 including intravitreal Triamcinolone
Concurrent Ocular Conditions
•Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either
Require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or
If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 12-month study period
•Active intraocular inflammation (grade trace or above) in the study eye
•Current vitreous hemorrhage in the study eye
•History of idiopathic or autoimmune-associated uveitis in either eye
•Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
•Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0
•Uncontrolled glaucoma in the study eye (defined as intraocular pressure ?30 mmHg despite treatment with anti-glaucoma medication)
•History of vitrectomy or complicated cataract surgery with rupture of the posterior lens capsule
Concurrent Systemic Conditions
•Any planned ocular surgery within the study period.
•Patients on anticoagulation therapy other than Aspirin.
•Premenopausal 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.
•History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
•Current treatment for active systemic infection
Other
•History of allergy to fluorescein, not amenable to treatment
•Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the investigators
•Inability to comply with study or follow up procedures

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To explore the structural and functional mechanisms of intravitreal Bevacizumab (Avastin™) on neovascular AMD as assessed by fundus photography, fluorescein angiography, optical coherence tomography, and microperimetry.<br><br>To evaluate ocular adverse events following intravitreal Bevacizumab (Avastin™).<br>;Primary end point(s): Visual acuity outcomes as measured by the ETDRS protocol in patients with CRVO/BRVO.;Main Objective: To investigate visual acuity outcomes following intravitreal Bevacizumab (Avastin™) in patients with BRVO and CRVO.<br>