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

NCT ID: NCT00220805

Last Updated: 2016-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2005-05-31

Brief 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).

Detailed Description

The purpose of this trial is to investigate the effect of IGIV-C in subjects suffering from AMD with occult CNV where fewer treatment options exist for patients with this disease form.

This study is designed as a randomized, double-blind, parallel group, placebo-controlled prospective trial. Sixty patients, 30 per treatment group, with newly diagnosed pure occult CNV defined by angiography diagnostic criteria will be enrolled. If a subject has more than one eye affected with occult CNV, the eye with the better vision as measured by visual acuity ( Logarithm of the Minimum Angle of Resolution [LogMAR] score) will be entered as the study eye.

Patients will be randomized to receive either IGIV-C at a dose of 2 g/kg body weight (bw) over 5 consecutive days or matching placebo. Additional 2 study drug treatment courses (IGIV-C or matching placebo) will be administered every 4 weeks at the same dose of 2 g/kg bw given over 5 days. Subjects' visual acuity will be measured and reported as LogMAR at screening, week 0 (baseline), day 5, week 4, week 8 and week 12. If at anytime during the study the subject's visual acuity worsens by ≥ 2 lines (0.2 on the LogMAR score), then a slit lamp examination will be performed and an angiogram will be conducted; the patient would be discontinued if the worsening is due to some other reason outside of the occult CNV or if the disease has changed from pure occult to the classic or mixed form.

Subjects will be evaluated for efficacy (LogMAR score) at endpoint (at week 12 or at last LogMAR assessment at or after week 8, if the subject prematurely discontinues the trial).

At the end of the treatment period (week 12), patients will be entered into a 3 month observation period with monthly visual acuity LogMAR score assessments.

Conditions

Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

Group Type: EXPERIMENTAL

Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified

Intervention Type: DRUG

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.

Group 2

Group Type: PLACEBO_COMPARATOR

Albumin (Human) 25%, United States Pharmacopeia (USP)

Intervention Type: DRUG

Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.

Interventions

Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified

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.

Intervention Type: DRUG

Albumin (Human) 25%, United States Pharmacopeia (USP)

Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.

Intervention Type: DRUG

Other Intervention Names

Gamunex®; IGIVnex®; Gaminex; IGIV-C; IGIV-C, 10%; Immune Globulin IV (Human), 10% (IGIV); Immune Globulin IV (Human), 10% by Chromatography Process; IGIV; IVIG; BAY 41-1000; TAL-05-00004; NDC 13533-645-12; NDC 13533-645-15; NDC 13533-645-20; NDC 13533-645-24; NDC 13533-645-71; Plasbumin®-20; Plasbumin®-25; Plasbumin®-20 (Low Aluminum); Plasbumin®-25 (Low Aluminum); Albumin (Human) 20%, USP; TAL-05-00007; TAL-05-00008; TAL-05-00024; TAL-05-00025; BAY 34-9255; NDC 13533-683-20; NDC 13533-683-71; NDC 13533-684-16; NDC 13533-684-20; NDC 13533-684-71; NDC 13533-691-20; NDC 13533-691-71; NDC 13533-692-16; NDC 13533-692-20; NDC 13533-692-71

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.

• Minimum Eligible Age: 51 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Therapeutics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Brunner, MD

Role: PRINCIPAL_INVESTIGATOR

Center of Ophthalmology, University of Cologne, Germany

Locations

Universitatsklinikum Aachen, Augenklinik

Aachen, , Germany

Medizinische Einrichtungen der Universitat zu Koln, Centrum fur Augenheilkunde

Cologne, , Germany

Augenklinik Tausendfensterhaus

Duisburg, , Germany

St. Martinus-Krankenhaus, Augenabteilung

Düsseldorf, , Germany

Medizinische Eirnrichtungen der Universitat Essen, Klinik fur Erkrankungen des hinteren Augenabschnittes

Essen, , Germany

Kliniken und Polikliniken der Albert Ludwigs Universität

Freiburg im Breisgau, , Germany

Klininkum der Eberhard-Karls-Universitat Tubingen, Universitats-Augenklinik

Tübingen, , Germany

Countries

Germany

Related Links

http://www.talecris-pi.info/inserts/gamunex.pdf

FDA Approved Product Labeling Information - Gamunex®

http://www.talecris-pi.info/inserts/plasbumin20la.pdf

FDA Approved Product Labeling Information - Plasbumin®-20 (Low Aluminum)

http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm089390.htm

FDA Product Approval

http://www.talecris-pi.info/inserts/plasbumin25la.pdf

FDA Approved Product Labeling Information - Plasbumin®-25 (Low Aluminum)

Other Identifiers

100586

Identifier Type: -

Identifier Source: org_study_id