Status:
COMPLETED
Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration
Lead Sponsor:
Grifols Therapeutics LLC
Conditions:
Macular Degeneration
Eligibility:
All Genders
51+ years
Phase:
PHASE2
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 Degener...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00220805
Start Date
January 1 2004
End Date
May 1 2005
Last Update
March 21 2016
Active Locations (7)
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1
Universitatsklinikum Aachen, Augenklinik
Aachen, Germany, 52074
2
Medizinische Einrichtungen der Universitat zu Koln, Centrum fur Augenheilkunde
Cologne, Germany, 50931
3
Augenklinik Tausendfensterhaus
Duisburg, Germany, 47119
4
St. Martinus-Krankenhaus, Augenabteilung
Düsseldorf, Germany, 40219