Phase 2
N=57
Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00220805 ↗Enrolled (actual)
57
Serious AEs
10.5%
Results posted
Mar 2016
Primary outcome: Primary: Mean Change in Visual Acuity (Logarithm of the Minimum Angle of Resolution [LogMAR]) Score From Baseline for IGIV-C, 10% Compared to Placebo at Week 12 or at Last LogMAR Assessment (Conducted at or After Week 8 of the Treatment Period) — 0.581; 0.533; 0.646; 0.557 LogMAR — p=0.49
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified (Drug); Albumin (Human) 25%, United States Pharmacopeia (USP) (Drug)
- Age
- Adult, Older Adult · 51+ yrs
- Sex
- All
- Sponsor
- Grifols Therapeutics LLC
- Primary completion
- May 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Visual Acuity (Logarithm of the Minimum Angle of Resolution [LogMAR]) Score From Baseline for IGIV-C, 10% Compared to Placebo at Week 12 or at Last LogMAR Assessment (Conducted at or After Week 8 of the Treatment Period) |
0.581; 0.533; 0.646; 0.557; 0.064; 0.024 | 0.49 |
| SECONDARY Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR |
24.1; 20.8 | 0.76 |
| SECONDARY Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR |
3.4; 16.7 | 0.13 |
| SECONDARY Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test) |
0.164; 0.159 | 0.90 |
| SECONDARY Proportion of Subjects With an Increase ≥ 2 or More Points in Lens Opacity Classification System (LOCS III) for Nuclear Opalescence, Nuclear Color, Cortical Cataract or Posterior Subcapsular Cataract Categories |
0; 0 | — |
| SECONDARY Presence of Fibrosis and Location Assessed by Slit-lamp |
1; 3 | 0.74 |
| SECONDARY Mean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center |
0.074; 0.173 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00220805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.