Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT00220805
Eligibility Criteria:
Inclusion Criteria:
* The best corrected visual acuity must be in the range of 20/40 to 20/200 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart (0.5 - 0.1).
* Patient complaint of visual loss within the last three months prior to study entry.
* Documented visual loss on a visual acuity chart in the 3-month period prior to the beginning of the run-in period.
* Signed written informed consent prior to initiation of any study-related procedures.
Exclusion Criteria:
* Treatment with IGIV within the last 3 months prior to the run-in.
* Previous photodynamic therapy (PDT) or vitrectomy or transpupillary thermotherapy (TTT) or any specific pre-treatment of CNV
* Subfoveal blood in the study eye if ≥ 1/2 disc diameter as measured by slit lamp during run-in period.
* History of anaphylaxis or severe systemic response to immunoglobulin or with a blood product.
* Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, or severe or uncontrolled hypertension (diastolic \> 95 mmHg or systolic \>170 mmHg)
* Females, who are pregnant, breast feeding, or if of childbearing potential, unwilling to practice adequate contraception throughout the study.
* History of renal insufficiency or serum creatinine levels \> 221 µmol/L (2.5 mg/dL).
* Known selective immunoglobulin A (IgA) deficiency
* Other investigational drugs received within the past 3 months.
* Conditions whose symptoms and effects could alter protein catabolism and/or immunoglobulin (IgG) utilization (e.g. protein-losing enteropathies, nephrotic syndrome).
* Known hypercoagulable state.
* Patients on continuous systemic steroid treatment
* Mentally challenged adult subjects who cannot give independent informed consent.
* History of thromboembolic events.
* Diabetes mellitus requiring drug treatment.
* Known severe hypersensitivity to sodium fluorescein.
* Acute or known ocular diseases such as glaucoma, arterial or venous occlusions, acute ischemic optic-neuropathy, impairment of visual acuity due to opacities in the lens (LOCSIII: NO 5-6 or C: 4-5 or P 4-5) or vitreous which may influence the evaluation of the therapeutic effect.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
51 Years
Study:
NCT00220805
Study Brief:
Protocol Section:
NCT00220805