Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate visual improvement in patients treated with Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) or placebo who have Age-Related Macular Degeneration (AMD) with occult Choroidal Neovascularization (CNV).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grifols Therapeutics Inc.; Grifols Therapeutics LLC
• Treatments: Antibodies; gamma-Globulins; Immunoglobulin G; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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.