Macular DegenerationPhase 2NCT00220805
Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration
A Phase 2 study testing Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified and Albumin (Human) 25%, United States Pharmacopeia (USP) in people with Macular Degeneration, run by Grifols Therapeutics LLC at 7 sites in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified and Albumin (Human) 25%, United States Pharmacopeia (USP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 7 sitesGermany
- Study dates
- Jan 2004to May 2005
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Universitatsklinikum Aachen, Augenklinik
Aachen, 52074
Medizinische Einrichtungen der Universitat zu Koln, Centrum fur Augenheilkunde
Cologne, 50931
Augenklinik Tausendfensterhaus
Duisburg, 47119
St. Martinus-Krankenhaus, Augenabteilung
Düsseldorf, 40219
Medizinische Eirnrichtungen der Universitat Essen, Klinik fur Erkrankungen des hinteren Augenabschnittes
Essen, 45147
Kliniken und Polikliniken der Albert Ludwigs Universität
Freiburg im Breisgau, 79106
Klininkum der Eberhard-Karls-Universitat Tubingen, Universitats-Augenklinik
Tübingen, 72076
About this study
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
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.
- Conditions
- Macular Degeneration
- Being tested
- Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified, Albumin (Human) 25%, United States Pharmacopeia (USP)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography PurifiedDrug
Also called Gamunex®, IGIVnex®, Gaminex, IGIV-C
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.
Albumin (Human) 25%, United States Pharmacopeia (USP)Drug
Also called Plasbumin®-20, Plasbumin®-25, Plasbumin®-20 (Low Aluminum), Plasbumin®-25 (Low Aluminum)
Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified |
| Group 2 | Placebo comparator | Not described Receives: Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (6)
Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR
Measured: Last measurement at or later than Week 8
Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR
Measured: Last measurement at or later than Week 8
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.
Measured: Last measurement at or later than Week 8
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.
Measured: Last measurement at or later than Week 8
Presence of Fibrosis and Location Assessed by Slit-lamp
Measured: Last measurement at or later than Week 8
Mean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center
Measured: At end of treatment (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Brunner, MD, Principal investigator, Center of Ophthalmology, University of Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220805
- Sponsor's protocol ID
- 100586
- Status last verified
- Feb 2016
- First submitted
- 14 Sep 2005
- Last updated
- 21 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00220805
- Acronym / sponsor ID
- 100586
- Conditions
- Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 21 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified |
| Group 2 | Placebo comparator | Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography PurifiedAlso: Gamunex®, IGIVnex®, Gaminex, IGIV-CThe 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. | Drug | Group 1 |
| Albumin (Human) 25%, United States Pharmacopeia (USP)Also: Plasbumin®-20, Plasbumin®-25, Plasbumin®-20 (Low Aluminum), Plasbumin®-25 (Low Aluminum)Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%. | Drug | Group 2 |
Primary outcome
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)
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
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.
6 secondary outcomes
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
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
Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test)
Time frame: Last measurement at or later than Week 8
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
Time frame: Last measurement at or later than Week 8
Presence of Fibrosis and Location Assessed by Slit-lamp
Time frame: Last measurement at or later than Week 8
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Approved Product Labeling Information - Gamunex®Link provided by the sponsor.
- FDA Approved Product Labeling Information - Plasbumin®-20 (Low Aluminum)Link provided by the sponsor.
- FDA Product ApprovalLink provided by the sponsor.
- FDA Approved Product Labeling Information - Plasbumin®-25 (Low Aluminum)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Brunner, MD principal investigator
Center of Ophthalmology, University of Cologne, Germany
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified and Albumin (Human) 25%, United States Pharmacopeia (USP) in people with Macular Degeneration, run by Grifols Therapeutics LLC at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2016.