Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified; Albumin (Human) 25%, United States Pharmacopeia (USP)
Intervention description: The dose per infusion cycle was 2 g/kg body weight over 5 consecutive days (= 4 mL/kg body weight/infusion). The infusion duration was approximately 1.5 - 2 h.; Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 51 Years
Healthy volunteers: No

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).
    

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.