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

This study has been completed.
Sponsor:
Information provided by:
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00220805
First received: September 14, 2005
Last updated: July 23, 2009
Last verified: April 2008
  Purpose

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).


Condition Intervention Phase
Macular Degeneration
Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
Drug: Albumin (Human) 25%, USP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-C, 10% Treatment in Subjects With Pure Occult Choroidal Neovascularization Due to Age Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Grifols Therapeutics Inc.:

Primary Outcome Measures:
  • - Mean change in visual acuity [LogMAR] score from baseline to endpoint compared to placebo [ Time Frame: (at week 12 or last LogMAR assessment conducted at or after week 8 of the treatment period) ]

Secondary Outcome Measures:
  • Proportion of subjects who improve visual acuity from baseline to endpoint by ≥ 0.1 LogMAR. [ Time Frame: 12 Weeks ]
  • Proportion of subjects who improve visual acuity from baseline to endpoint by ≥ 0.2 LogMAR. [ Time Frame: 12 Weeks ]
  • Mean change in LogRAD score from baseline to endpoint (RADNER-test). [ Time Frame: 12 Weeks ]
  • Proportion of subjects with an increase ≥ 2 or more points in LOCS III for nuclear opalescence, nuclear color, cortical cataract or posterior subcapsular cataract categories. [ Time Frame: 12 Weeks ]
  • Presence of fibrosis and location assessed by slit-lamp. [ Time Frame: 12 Weeks ]
  • Mean change from baseline to endpoint in size, type and location of lesions and leakage assessed by central fluorescein angiogram reading center. [ Time Frame: 12 Weeks ]

Enrollment: 57
Study Start Date: January 2004
Study Completion Date: May 2005
Arms Assigned Interventions
Experimental: Group 1 Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
Other Names:
  • Gamunex®
  • IGIVnex®
  • Gaminex
  • IGIV-C
  • IGIV-C, 10%
  • Immune Globulin Intravenous (Human), 10% (IGIV)
  • Immune Globulin Intravenous (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
Placebo Comparator: Group 2 Drug: Albumin (Human) 25%, USP
Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.
Other Names:
  • 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

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 (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.

  Eligibility

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The best corrected visual acuity must be in the range of 20/40 to 20/200 on the 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 PDT or vitrectomy or 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 IgA deficiency
  • Other investigational drugs received within the past 3 months.
  • Conditions whose symptoms and effects could alter protein catabolism and/or 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220805

Locations
Germany
Universitatsklinikum Aachen, Augenklinik
Aachen, Germany, 52074
Augenklinik Tausendfensterhaus
Duisburg, Germany, 47119
St. Martinus-Krankenhaus, Augenabteilung
Düsseldorf, Germany, 40219
Medizinische Eirnrichtungen der Universitat Essen, Klinik fur Erkrankungen des hinteren Augenabschnittes
Essen, Germany, 45147
Kliniken und Polikliniken der Albert Ludwigs Universität
Freiburg, Germany, 79106
Medizinische Einrichtungen der Universitat zu Koln, Centrum fur Augenheilkunde
Koln, Germany, 50931
Klininkum der Eberhard-Karls-Universitat Tubingen, Universitats-Augenklinik
Tubingen, Germany, 72076
Sponsors and Collaborators
Grifols Therapeutics Inc.
Investigators
Principal Investigator: Richard Brunner, MD Center of Ophthalmology, University of Cologne, Germany
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00220805     History of Changes
Other Study ID Numbers: 100586
Study First Received: September 14, 2005
Last Updated: July 23, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Albunex
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Antibodies
Immunoglobulins
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014