European Intravitreal Avastin® Trial 1 - EURIVAT1

Phase 1

• Conditions: eovascular / exudative age-related macular degeneration

• Registration Number: EUCTR2005-003132-21-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: 7 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Signed informed consent.
Age >50 years.
Primary subfoveal choroidal neovascularization lesions secondary to AMD in the study eye.
Best corrected visual acuity, using ETDRS charts, of 20/800 to 20/40 (Snellen equivalent) in the study eye.
Lesion size smaller than 4 disc areas as assessed by flourescein angiography.

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 subfoveal focal laser photocoagulation in the study eye.
Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0.
History of submacular surgery or other surgical intervention for AMD in the study eye.
Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).

Lesion characteristics:
Subfoveal fibrosis or atrophy in the study eye.

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 24-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 24-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 ocular hypertension in the study eye (defined as intraocular pressure >30 mmHg).

Concurrent systemic conditions:
History of any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of 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 fo active systemic infection.

Other:
History of allergy to fluorescein, not amenable to treatment.
Inability to obtain fundus photographs or flourescein angiograms of sufficient quality to be analyzed and graded by the central reading center.
Inability to comply with study or follow up procedures.

Study & Design

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