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CompletedNCT00220805Updated Mar 21, 2016Results posted

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

A Phase 2 interventional study of Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified and Albumin (Human) 25%, United States Pharmacopeia (USP) in Macular Degeneration, sponsored by Grifols Therapeutics LLC. Completed at 7 sites in Germany. Open to participants aged 51 Years and older. Per ClinicalTrials.gov, last updated 2016-03-21.

Sponsored by Grifols Therapeutics LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
51 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 96 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Grifols Therapeutics LLC is the lead sponsor of 43 studies on the registry; 4 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
51 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Group 1

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

  • Placebo comparator
    Group 2

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

Interventions

  • DrugImmune 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.

    Also known as: 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

  • DrugAlbumin (Human) 25%, United States Pharmacopeia (USP)

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

    Also known as: 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

06

What researchers measure

Primary outcomes

  1. 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)

    Using the LogMAR score, lower values correspond to higher visual acuity. For example, a visual acuity of 20/20 corresponds to a LogMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7.

    Time frame: At Week 12 or, if the Week 12 assessment is not available, at the last LogMAR assessment conducted at or after Week 8 of the Treatment Period

Secondary outcomes

  1. Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR

    Time frame: Last measurement at or later than Week 8

  2. Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR

    Time frame: Last measurement at or later than Week 8

  3. Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test)

    The RADNER test gives not only information about the subject's reading performance, but also about the reading speed (life quality) and the faults while reading. The RADNER reading charts (1, 2, and 3) contain sentences in paragraphs having a range of print sizes starting with the largest print at the top.The subject was randomly assigned one of the RADNER charts, and the charts were different between consecutive visits. The reading distance was 25 cm. The subject's score was corrected for reading speed and errors. The range of possible logRAD scores was from 2.0 (could not read the first paragraph) to -0.2, with higher scores indicating lower reading acuity and lower scores indicating higher reading acuity.

    Time frame: Last measurement at or later than Week 8

  4. 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

    The LOCS III scale for cortical cataract and posterior subcapsular cataract opacity ranged from 1.0 to 5.0. The LOCS III scale for nuclear opalescence and for nuclear color was 1.0 to 6.0. For all scales, higher values indicate higher opacity, opalescence, or color.

    Time frame: Last measurement at or later than Week 8

  5. Presence of Fibrosis and Location Assessed by Slit-lamp

    Time frame: Last measurement at or later than Week 8

  6. Mean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center

    Time frame: At end of treatment (12 weeks)

07

Results

Posted Mar 21, 2016

Participant flow

A total of 96 subjects were enrolled (signed the informed consent and screened) in this study at 6 German study centers.

Participant flow — Overall Study
MilestoneIGIV-C 10%Placebo
Started3027
Completed2216
Not completed811
Withdrew: Adverse event13
Withdrew: Withdrawal by subject30
Withdrew: Lack of efficacy10
Withdrew: Develop. of choroidal neovascularization38

Outcome measures

PrimaryMean 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)

Using the LogMAR score, lower values correspond to higher visual acuity. For example, a visual acuity of 20/20 corresponds to a LogMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7.

Time frame:
At Week 12 or, if the Week 12 assessment is not available, at the last LogMAR assessment conducted at or after Week 8 of the Treatment Period
Reported as:
Mean · LogMAR
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)
LogMARIGIV-C 10%Placebo
Baseline0.581 ± 0.2090.533 ± 0.153
End of treatment (EOT) Week 12 or last assessment0.646 ± 0.3090.557 ± 0.244
Change End of treatment (EOT) minus Baseline0.064 ± 0.2200.024 ± 0.182
Statistical analysis
  • IGIV-C 10% vs Placebo · ANOVA · p = 0.49
SecondaryProportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR
Time frame:
Last measurement at or later than Week 8
Reported as:
Number · percentage of participants
Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR
percentage of participantsIGIV-C 10%Placebo
Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR24.120.8
Statistical analysis
  • IGIV-C 10% vs Placebo · Cochran-Mantel-Haenszel · p = 0.76 (Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers))
SecondaryProportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR
Time frame:
Last measurement at or later than Week 8
Reported as:
Number · percentage of participants
Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR
percentage of participantsIGIV-C 10%Placebo
Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR3.416.7
Statistical analysis
  • IGIV-C 10% vs Placebo · Cochran-Mantel-Haenszel · p = 0.13Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)
SecondaryMean Change in LogRAD Score From Baseline to Endpoint (RADNER Test)

The RADNER test gives not only information about the subject's reading performance, but also about the reading speed (life quality) and the faults while reading. The RADNER reading charts (1, 2, and 3) contain sentences in paragraphs having a range of print sizes starting with the largest print at the top.The subject was randomly assigned one of the RADNER charts, and the charts were different between consecutive visits. The reading distance was 25 cm. The subject's score was corrected for reading speed and errors. The range of possible logRAD scores was from 2.0 (could not read the first paragraph) to -0.2, with higher scores indicating lower reading acuity and lower scores indicating higher reading acuity.

Time frame:
Last measurement at or later than Week 8
Reported as:
Mean · LogRAD
Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test)
LogRADIGIV-C 10%Placebo
Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test)0.164 ± 0.3430.159 ± 0.371
Statistical analysis
  • IGIV-C 10% vs Placebo · ANOVA · p = 0.90 · Mean difference (final values): -0.01 · 95% CI -0.21 to 0.19
SecondaryProportion 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

The LOCS III scale for cortical cataract and posterior subcapsular cataract opacity ranged from 1.0 to 5.0. The LOCS III scale for nuclear opalescence and for nuclear color was 1.0 to 6.0. For all scales, higher values indicate higher opacity, opalescence, or color.

Time frame:
Last measurement at or later than Week 8
Reported as:
Number · participants
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
participantsIGIV-C 10%Placebo
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 Categories00
SecondaryPresence of Fibrosis and Location Assessed by Slit-lamp
Time frame:
Last measurement at or later than Week 8
Reported as:
Number · participants
Presence of Fibrosis and Location Assessed by Slit-lamp
participantsIGIV-C 10%Placebo
Presence of Fibrosis and Location Assessed by Slit-lamp13
Statistical analysis
  • IGIV-C 10% vs Placebo · Cochran-Mantel-Haenszel · p = 0.74Adjusted to centers
SecondaryMean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center
Time frame:
At end of treatment (12 weeks)
Reported as:
Mean · Disk Diameter
Mean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center
Disk DiameterIGIV-C 10%Placebo
Mean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center0.074 ± 0.2090.173 ± 0.298

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IGIV-C 10%—1/30 (3.3%)21/30 (70%)
Placebo—5/27 (18.5%)15/27 (55.6%)
Most frequent serious events
Most frequent serious events
EventIGIV-C 10%Placebo
Cerebrovascular accidentNervous system disorders0/301/27
Transient ischemic attackNervous system disorders0/301/27
CholelithiasisHepatobiliary disorders0/301/27
Abdominal pain, upperGastrointestinal disorders0/301/27
Brain neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/301/27
Stent placementSurgical and medical procedures1/300/27
Most frequent other events
Showing 10 of 13
Most frequent other events
EventIGIV-C 10%Placebo
NauseaGastrointestinal disorders2/303/27
Blood pressure increasedInvestigations2/303/27
Abdominal pain, upperGastrointestinal disorders0/302/27
Blood urea increasedInvestigations2/302/27
CoughRespiratory, thoracic and mediastinal disorders1/302/27
PruritisSkin and subcutaneous tissue disorders0/302/27
VertigoEar and labyrinth disorders2/301/27
FatigueGeneral disorders2/300/27
CystitisInfections and infestations2/300/27
Hand fractureInjury, poisoning and procedural complications2/300/27

Baseline characteristics

The intent to treat (ITT) population, which was defined as the primary analysis population, comprised 29 subjects treated with IGIV-C 10% and 24 subjects treated with placebo. A total of 4 subjects were excluded from the ITT population: 1 from IGIV-C 10% and 3 from Placebo.

Age, Categorical
Age, Categorical(Participants)IGIV-C 10%PlaceboTotal
<=18 years000
Between 18 and 65 years448
>=65 years252045
Age, Continuous
Age, Continuous(years)IGIV-C 10%PlaceboTotal
Mean74.724 ± 8.41774.042 ± 10.21774.415 ± 9.189
Sex: Female, Male
Sex: Female, Male(Participants)IGIV-C 10%PlaceboTotal
Female201737
Male9716
Region of Enrollment
Region of Enrollment(participants)IGIV-C 10%PlaceboTotal
Germany292453
Visual Acuity Score (VAS) of the Study Eyes
Visual Acuity Score (VAS) of the Study Eyes(units on a scale)IGIV-C 10%PlaceboTotal
Mean55.9 ± 10.458.4 ± 7.757.0 ± 9.3
Logarithm of the Minimum Angle of Resolution (LogMAR) of the Study Eyes
Logarithm of the Minimum Angle of Resolution (LogMAR) of the Study Eyes(LogMAR)IGIV-C 10%PlaceboTotal
Mean0.581 ± 0.2090.533 ± 0.1530.559 ± 0.186
08

Study locations

7 sites
  • Universitatsklinikum Aachen, Augenklinik
    Aachen, 52074, Germany
  • Augenklinik Tausendfensterhaus
    Duisburg, 47119, Germany
  • St. Martinus-Krankenhaus, Augenabteilung
    Düsseldorf, 40219, Germany
  • Medizinische Eirnrichtungen der Universitat Essen, Klinik fur Erkrankungen des hinteren Augenabschnittes
    Essen, 45147, Germany
  • Kliniken und Polikliniken der Albert Ludwigs Universität
    Freiburg, 79106, Germany
  • Medizinische Einrichtungen der Universitat zu Koln, Centrum fur Augenheilkunde
    Koln, 50931, Germany
  • Klininkum der Eberhard-Karls-Universitat Tubingen, Universitats-Augenklinik
    Tubingen, 72076, Germany
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00220805
Lead sponsor
Grifols Therapeutics LLC
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Jan 2004
Primary completion
May 2005
Completion
May 2005
Results posted
Mar 21, 2016
Last update
Mar 21, 2016

Study contacts

Richard Brunner, MD
principal investigator · Center of Ophthalmology, University of Cologne, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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